Trial Outcomes & Findings for LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair (NCT NCT03551509)

Results Overview

Success as defined by tendon healing after rotator cuff repair, as indicated based on MRI

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

As assessed 1 year postoperatively.

Results posted on

2025-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Control Treatment Group Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Overall Study STARTED	4	4	1
Overall Study COMPLETED	4	3	1
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Treatment Group Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Overall Study Lost to Follow-up	0	1	0

Baseline Characteristics

LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants	3 Participants n=4 Participants	0 Participants n=27 Participants	6 Participants n=483 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Age, Continuous	60.25 Years STANDARD_DEVIATION 4.57 • n=93 Participants	62.66 Years STANDARD_DEVIATION 2.08 • n=4 Participants	76.00 Years n=27 Participants	63.12 Years STANDARD_DEVIATION 6.22 • n=483 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	3 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	5 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	7 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	4 participants n=93 Participants	3 participants n=4 Participants	1 participants n=27 Participants	8 participants n=483 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification System ASA 1	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification System ASA 2	0 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification System ASA 3	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Smoking Status Never Smoked	4 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants
Smoking Status Former Smoker	0 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants
Smoking Status Smoker	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Body Mass Index	31.36 Kg/m^2 STANDARD_DEVIATION 2.75 • n=93 Participants	31.59 Kg/m^2 STANDARD_DEVIATION 6.21 • n=4 Participants	23.21 Kg/m^2 n=27 Participants	30.43 Kg/m^2 STANDARD_DEVIATION 4.77 • n=483 Participants

PRIMARY outcome

Timeframe: As assessed 1 year postoperatively.

Success as defined by tendon healing after rotator cuff repair, as indicated based on MRI

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Tendon Healing	0 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: As assessed 1 year postoperatively.

Comparison of tendon healing will be assessed using US imaging modalities versus MRI (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Comparison of Healing by MRI vs US	0 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: As assessed at 6 weeks postoperatively.

Population: Ultrasound was not performed in one patient of the control group

Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Progress of Tendon Healing	3 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: As assessed at 3 months postoperatively.

Population: Ultrasound was not performed in 2 patients of the control group

Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

Outcome measures

Outcome measures
Measure	Control Treatment Group n=2 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Progress of Tendon Healing	1 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: As assessed at 6 months postoperatively.

Population: Ultrasound was not performed in one patient of the control group

Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Progress of Tendon Healing	3 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: As assessed at 9 months postoperatively.

Progress of tendon healing based on US will be used as predictive data for 1 year success (based on primary outcome) (Success as defined by tendon healing after rotator cuff repair, as indicated based on US)

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Progress of Tendon Healing	0 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Preoperative

The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	50.75 Units on a scale Standard Deviation 20.15	37.66 Units on a scale Standard Deviation 15.69	52.00 Units on a scale

SECONDARY outcome

Timeframe: 6 weeks after surgery

The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	58.25 Units on a scale Standard Deviation 20.20	58.66 Units on a scale Standard Deviation 21.00	45.00 Units on a scale

SECONDARY outcome

Timeframe: 3 months after surgery

Population: One patient in the control group and another in the alternative group did not complete the survey

The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	66.66 Units on a scale Standard Deviation 21.38	74.00 Units on a scale Standard Deviation 19.05	—

SECONDARY outcome

Timeframe: 6 months after surgery

Population: One patient in the control group and another in the alternative group did not complete the survey

The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	73.00 Units on a scale Standard Deviation 26.51	77.00 Units on a scale Standard Deviation 16.52	—

SECONDARY outcome

Timeframe: 9 months after surgery

The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	82.75 Units on a scale Standard Deviation 21.96	77.66 Units on a scale Standard Deviation 7.50	60.00 Units on a scale

SECONDARY outcome

Timeframe: 1 year after surgery

The ASES is standardized form for assessment of the shoulder. The patient self-evaluation section form contains visual analog scales for pain and activities of daily living questionnaire. The activities of daily living questionnaire is marked on a four-point ordinal scale that can be converted to a cumulative activities of daily living index. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%). Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The American Shoulder and Elbow Surgeon Shoulder Score (ASES)	85.00 Units on a scale Standard Deviation 15.03	88.00 Units on a scale Standard Deviation 6.55	55.00 Units on a scale

SECONDARY outcome

Timeframe: Preoperative

A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	34.25 Percentage of highest functional level Standard Deviation 19.61	30.00 Percentage of highest functional level Standard Deviation 11.26	20.00 Percentage of highest functional level

SECONDARY outcome

Timeframe: 6 weeks after surgery

A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	63.50 Percentage of highest functional level Standard Deviation 14.34	53.66 Percentage of highest functional level Standard Deviation 25.92	26.00 Percentage of highest functional level

SECONDARY outcome

Timeframe: 3 months after surgery

Population: The patient in the alternative group did not complete the survey

A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	64.25 Percentage of highest functional level Standard Deviation 17.30	65.00 Percentage of highest functional level Standard Deviation 30.64	—

SECONDARY outcome

Timeframe: 6 months after surgery

Population: One patient in the control group and another in the alternative group did not complete the survey

A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=2 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	65.33 Percentage of highest functional level Standard Deviation 26.57	78.00 Percentage of highest functional level Standard Deviation 18.38	—

SECONDARY outcome

Timeframe: 9 months after surgery

A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	71.50 Percentage of highest functional level Standard Deviation 24.20	86.00 Percentage of highest functional level Standard Deviation 7.00	54.00 Percentage of highest functional level

SECONDARY outcome

Timeframe: 1 year after surgery

A disease-specific quality of life measurement tool for patients with rotator cuff disease. Patients will respond to by marking a scale with ranges between none and extreme. Information collected includes physical symptoms, such as pain and weakness levels in the shoulder, the impact of the patient's shoulder injury on their sports/recreational activities, work (inside or outside of the home), lifestyle/activities of daily living (ADL), and its emotional impact, such as frustration level, depression, and any worry/concern a patient might be about how their injury might affect their occupation. Total final WORC scores range from 0% to 100%. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: The Western Ontario Rotator Cuff Index (WORC)	91.50 Percentage of highest functional level Standard Deviation 15.02	94.33 Percentage of highest functional level Standard Deviation 7.37	41.00 Percentage of highest functional level

SECONDARY outcome

Timeframe: Preoperative

This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Measurement of Shoulder Activity Level	4.75 Units on a scale Standard Deviation 5.25	2.00 Units on a scale Standard Deviation 2.64	3.00 Units on a scale

SECONDARY outcome

Timeframe: 6 weeks after surgery

Population: One patient in the treatment group did not complete the survey

This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=2 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Measurement of Shoulder Activity Level	2.25 Units on a scale Standard Deviation 1.70	8.50 Units on a scale Standard Deviation 12.02	14.00 Units on a scale

SECONDARY outcome

Timeframe: 3 months after surgery

Population: The patient in the alternative group did not complete the survey

This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Measurement of Shoulder Activity Level	8.25 Units on a scale Standard Deviation 6.65	4.66 Units on a scale Standard Deviation 7.23	—

SECONDARY outcome

Timeframe: 6 months after surgery

Population: One patient in the control group did not complete the survey

This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Measurement of Shoulder Activity Level	10.66 Units on a scale Standard Deviation 8.14	10.66 Units on a scale Standard Deviation 9.01	9.00 Units on a scale

SECONDARY outcome

Timeframe: 9 months after surgery

This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Measurement of Shoulder Activity Level	7.50 Units on a scale Standard Deviation 6.55	12.00 Units on a scale Standard Deviation 4.00	2.00 Units on a scale

SECONDARY outcome

Timeframe: 1 year after surgery

This activity scale was developed using established principles: item generation, item reduction, pretesting, and reliability and validity testing. The activity rating is a numerical sum of scores for five activities rated on a five-point frequency scale from never performed (0 points) to daily (4 points). Patients were scored on the following criteria: carrying an object 8 lb or heavier by hand, handling objects overhead, weight training with arms, swinging motion (i.e., hitting tennis or golf ball), and lifting objects 25 lb or heavier. It can be used in conjunction with patient-based measures of shoulder outcome to define patient populations for cohort studies, and to assess activity level as a prognostic factor in patients with shoulder disorders. Scores range from 0 to 20. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Measurement of Shoulder Activity Level	12.50 Units on a scale Standard Deviation 5.80	11.33 Units on a scale Standard Deviation 8.50	0.00 Units on a scale

SECONDARY outcome

Timeframe: Preoperative

The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Subjective Shoulder Value (SSV)	32.50 percentage of entirely normal shoulder Standard Deviation 5.00	36.66 percentage of entirely normal shoulder Standard Deviation 15.27	20.00 percentage of entirely normal shoulder

SECONDARY outcome

Timeframe: 6 weeks after surgery

The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Subjective Shoulder Value (SSV)	57.75 percentage of entirely normal shoulder Standard Deviation 40.08	60.00 percentage of entirely normal shoulder Standard Deviation 20.00	40.00 percentage of entirely normal shoulder

SECONDARY outcome

Timeframe: 3 months after surgery

Population: The patient in the alternative group did not complete the survey

The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Subjective Shoulder Value (SSV)	76.25 percentage of entirely normal shoulder Standard Deviation 12.50	78.33 percentage of entirely normal shoulder Standard Deviation 12.58	—

SECONDARY outcome

Timeframe: 6 months after surgery

Population: One patient in the control group and another in the treatment group did not complete the survey

The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=2 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Subjective Shoulder Value (SSV)	71.66 percentage of entirely normal shoulder Standard Deviation 22.54	82.50 percentage of entirely normal shoulder Standard Deviation 10.60	75.00 percentage of entirely normal shoulder

SECONDARY outcome

Timeframe: 9 months after surgery

The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Subjective Shoulder Value (SSV)	72.50 percentage of entirely normal shoulder Standard Deviation 26.29	83.33 percentage of entirely normal shoulder Standard Deviation 15.27	80.00 percentage of entirely normal shoulder

SECONDARY outcome

Timeframe: 1 year after surgery

The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. Scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Subjective Shoulder Value (SSV)	85.75 percentage of entirely normal shoulder Standard Deviation 14.56	91.66 percentage of entirely normal shoulder Standard Deviation 2.88	75.00 percentage of entirely normal shoulder

SECONDARY outcome

Timeframe: Preoperative

C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Constant Score (CS)	12.75 Units on a scale Standard Deviation 3.59	10.66 Units on a scale Standard Deviation 6.65	9.00 Units on a scale

SECONDARY outcome

Timeframe: 6 weeks after surgery

Population: One patient in the control group did not complete the survey

C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Constant Score (CS)	18.33 Units on a scale Standard Deviation 0.57	15.00 Units on a scale Standard Deviation 2.64	13.00 Units on a scale

SECONDARY outcome

Timeframe: 3 months after surgery

Population: The patient in the alternative group did not complete the survey

C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Constant Score (CS)	20.00 Units on a scale Standard Deviation 3.55	18.00 Units on a scale Standard Deviation 3.46	—

SECONDARY outcome

Timeframe: 6 months after surgery

Population: One patient in the control group did not complete the survey

C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Constant Score (CS)	18.00 Units on a scale Standard Deviation 5.56	21.33 Units on a scale Standard Deviation 4.16	27.00 Units on a scale

SECONDARY outcome

Timeframe: 9 months after surgery

C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Constant Score (CS)	21.00 Units on a scale Standard Deviation 6.97	20.33 Units on a scale Standard Deviation 0.57	14.00 Units on a scale

SECONDARY outcome

Timeframe: 1 year after surgery

Population: One patient in the control group did not complete the survey

C Constant and A Murley. This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and ADL (sleep, work, recreation / sport) which give a total of 35 points. Constant subjective scale goes from 0 to 35. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Patient Outcomes: Constant Score (CS)	20.33 Units on a scale Standard Deviation 4.50	15.66 Units on a scale Standard Deviation 4.50	15.00 Units on a scale

SECONDARY outcome

Timeframe: Preoperative

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	42.50 Units on a scale Standard Deviation 3.10	39.33 Units on a scale Standard Deviation 6.50	38.00 Units on a scale

SECONDARY outcome

Timeframe: 6 weeks after surgery

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	43.00 Units on a scale Standard Deviation 6.68	43.33 Units on a scale Standard Deviation 4.16	37.00 Units on a scale

SECONDARY outcome

Timeframe: 3 months after surgery

Population: One patient in the treatment group and another in the alternative group did not complete the survey

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=2 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	52.50 Units on a scale Standard Deviation 1.29	45.50 Units on a scale Standard Deviation 12.02	—

SECONDARY outcome

Timeframe: 6 months after surgery

Population: One patient in the control group did not complete the survey

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	48.66 Units on a scale Standard Deviation 9.60	50.00 Units on a scale Standard Deviation 8.71	49.00 Units on a scale

SECONDARY outcome

Timeframe: 9 months after surgery

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	53.00 Units on a scale Standard Deviation 8.71	50.66 Units on a scale Standard Deviation 3.78	48.00 Units on a scale

SECONDARY outcome

Timeframe: 1 year after surgery

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Physical Component Score)	57.25 Units on a scale Standard Deviation 3.50	54.33 Units on a scale Standard Deviation 8.38	37.00 Units on a scale

SECONDARY outcome

Timeframe: Preoperative

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	43.50 Units on a scale Standard Deviation 8.34	37.66 Units on a scale Standard Deviation 19.85	53.00 Units on a scale

SECONDARY outcome

Timeframe: 6 weeks after surgery

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	48.00 Units on a scale Standard Deviation 7.34	31.33 Units on a scale Standard Deviation 4.50	59.00 Units on a scale

SECONDARY outcome

Timeframe: 3 months after surgery

Population: One patient in the treatment group and another in the alternative group did not complete the survey

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=2 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	37.75 Units on a scale Standard Deviation 5.67	38.50 Units on a scale Standard Deviation 2.12	—

SECONDARY outcome

Timeframe: 6 months after surgery

Population: One patient in the control group did not complete the survey

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=3 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	47.00 Units on a scale Standard Deviation 9.84	33.66 Units on a scale Standard Deviation 11.84	41.00 Units on a scale

SECONDARY outcome

Timeframe: 9 months after surgery

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	40.25 Units on a scale Standard Deviation 9.50	33.33 Units on a scale Standard Deviation 5.85	47.00 Units on a scale

SECONDARY outcome

Timeframe: 1 year after surgery

The Veterans RAND 12 Item Health Survey (VR-12) was designed to replicate much of the behavior of the Veterans RAND 36 Item Health Survey (VR-36) with a reduced number of questions. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). These summary scores range from 0 to 100. The higher the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Control Treatment Group n=4 Participants Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 Participants Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 Participants Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
The Veterans RAND 12 Item Health Survey (VR-12) (Mental Component Score)	37.25 Units on a scale Standard Deviation 9.77	33.66 Units on a scale Standard Deviation 9.07	53.00 Units on a scale

Adverse Events

Control Treatment Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Treatment Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Alternative Treatment Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control Treatment Group n=4 participants at risk Patients randomly assigned into the control group will undergo open or arthroscopic rotator cuff repair using the surgeon's standard practice. No ECM graft will be used. Control: This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.	Treatment Group n=3 participants at risk Patients randomly assigned into the treatment group will undergo open or arthroscopic rotator cuff repair with A-FLEX graft to augment the repair. ECM scaffold grafts are indicated for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery, including rotator cuff. ArthroFLEX ECM scaffold graft: In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.	Alternative Treatment Group n=1 participants at risk Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures. Alternative Treatment Group: Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Eye disorders Dry eyes	0.00% 0/4 • Within 1 year after surgery	0.00% 0/3 • Within 1 year after surgery	100.0% 1/1 • Number of events 1 • Within 1 year after surgery
Eye disorders Posterior vitrous detachment	0.00% 0/4 • Within 1 year after surgery	0.00% 0/3 • Within 1 year after surgery	100.0% 1/1 • Number of events 1 • Within 1 year after surgery
Musculoskeletal and connective tissue disorders Pain from shoulder to hand	0.00% 0/4 • Within 1 year after surgery	33.3% 1/3 • Number of events 1 • Within 1 year after surgery	0.00% 0/1 • Within 1 year after surgery
Nervous system disorders Dizziness	0.00% 0/4 • Within 1 year after surgery	33.3% 1/3 • Number of events 1 • Within 1 year after surgery	0.00% 0/1 • Within 1 year after surgery
Musculoskeletal and connective tissue disorders Low back pain	0.00% 0/4 • Within 1 year after surgery	33.3% 1/3 • Number of events 1 • Within 1 year after surgery	0.00% 0/1 • Within 1 year after surgery
Cardiac disorders Atypical chest pain	25.0% 1/4 • Number of events 1 • Within 1 year after surgery	0.00% 0/3 • Within 1 year after surgery	0.00% 0/1 • Within 1 year after surgery
Musculoskeletal and connective tissue disorders Back muscle spasm	25.0% 1/4 • Number of events 1 • Within 1 year after surgery	0.00% 0/3 • Within 1 year after surgery	0.00% 0/1 • Within 1 year after surgery
Musculoskeletal and connective tissue disorders Foot pain	25.0% 1/4 • Number of events 1 • Within 1 year after surgery	0.00% 0/3 • Within 1 year after surgery	0.00% 0/1 • Within 1 year after surgery
Injury, poisoning and procedural complications Hip contusion	25.0% 1/4 • Number of events 1 • Within 1 year after surgery	0.00% 0/3 • Within 1 year after surgery	0.00% 0/1 • Within 1 year after surgery
Musculoskeletal and connective tissue disorders Shoulder tear (contralateral)	25.0% 1/4 • Number of events 1 • Within 1 year after surgery	0.00% 0/3 • Within 1 year after surgery	0.00% 0/1 • Within 1 year after surgery
Infections and infestations Covid-19 positive	25.0% 1/4 • Number of events 1 • Within 1 year after surgery	0.00% 0/3 • Within 1 year after surgery	0.00% 0/1 • Within 1 year after surgery

Additional Information

Dr. Gregory Gilot

Cleveland Clinic

Phone: 786 566-9176

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place