Trial Outcomes & Findings for Types of Fixation in Arthroscopic Rotator Cuff Repair (NCT NCT00508183)

Results Overview

Do patients who undergo a repair of the rotator cuff with arthroscopic technique using double row fixation have increased disease specific quality of life (measured by WORC) then patients who undergo a repair with arthroscopic technique using single-row fixation? The WORC scale is from 0% to 100%, with a higher value being indicative of better disease specific quality of life.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

2 years

Results posted on

2020-04-01

Participant Flow

Enrollment occurred from June 2007 to June 2009 at The Ottawa Hospital in Ottawa,Ontario, and the PanAm Clinic in Winnipeg, Manitoba. The target population was men and women of any age with a diagnosis of a full-thickness tear of the rotator cuff according to clinical criteria.

Nine patients were never randomized because they either postponed or canceled the surgery, and nineteen patients were excluded prior to randomization for other reasons.

Participant milestones

Participant milestones
Measure	Single Row Fixation single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.	Double Row Fixation double row fixation: This technique, "double row" fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair.
Overall Study STARTED	48	42
Overall Study COMPLETED	39	34
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Types of Fixation in Arthroscopic Rotator Cuff Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Row Fixation n=48 Participants single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.	Double Row Fixation n=42 Participants double row fixation: This technique, "double row" fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair.	Total n=90 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 8.9 • n=5 Participants	57.8 years STANDARD_DEVIATION 7 • n=7 Participants	56.8 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	29 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment Canada	48 participants n=5 Participants	42 participants n=7 Participants	90 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Do patients who undergo a repair of the rotator cuff with arthroscopic technique using double row fixation have increased disease specific quality of life (measured by WORC) then patients who undergo a repair with arthroscopic technique using single-row fixation? The WORC scale is from 0% to 100%, with a higher value being indicative of better disease specific quality of life.

Outcome measures

Outcome measures
Measure	Single Row Fixation n=39 Participants single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.	Double Row Fixation n=34 Participants double row fixation: This technique, "double row" fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair.
Western Ontario Rotator Cuff Index (WORC)	84.4 units on a scale Standard Deviation 21.3	81.7 units on a scale Standard Deviation 20.9

SECONDARY outcome

Timeframe: 2 Year

Differences in outcome between the two groups as measured by the Constant score. The constant score ranges from 1 to 100 with a higher value indicative of better shoulder function.

Outcome measures

Outcome measures
Measure	Single Row Fixation n=39 Participants single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.	Double Row Fixation n=34 Participants double row fixation: This technique, "double row" fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair.
Constant Score	85.6 units on a scale Standard Deviation 14	86.3 units on a scale Standard Deviation 14.2

SECONDARY outcome

Timeframe: 2 Year

Determination of differences in outcome between the two groups as measured by the American Shoulder and Elbow Surgeons (ASES) score. The ASES score ranges from 0 to 100 with a higher number indicative of better function.

Outcome measures

Outcome measures
Measure	Single Row Fixation n=39 Participants single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.	Double Row Fixation n=34 Participants double row fixation: This technique, "double row" fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair.
ASES Score	87.9 units on a scale Standard Deviation 16.9	89.3 units on a scale Standard Deviation 17.5

SECONDARY outcome

Timeframe: 2 Years

Shoulder strength in forward elevation was measured in kg using a portable scale.

Outcome measures

Outcome measures
Measure	Single Row Fixation n=39 Participants single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.	Double Row Fixation n=34 Participants double row fixation: This technique, "double row" fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair.
Strength Test	8.0 kg Standard Deviation 6	7.3 kg Standard Deviation 3.2

SECONDARY outcome

Timeframe: 1 Year

Percentage of Participants who had healed by 1 year post-surgery as measured using magnetic resonance imaging. If the tendons were in continuity with no evidence of full-thickness tearing, the repair was considered healed (intact).

Outcome measures

Outcome measures
Measure	Single Row Fixation n=39 Participants single row: This method involves using a single row of anchor(s) to reattach the cuff to the bone.	Double Row Fixation n=34 Participants double row fixation: This technique, "double row" fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair.
Healing Rate	67 percentage of patients	78 percentage of patients

Adverse Events

Single Row Fixation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Double Row Fixation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter Lapner

Ottawa Hospital Research Institute

Phone: 613-737-8899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place