Trial Outcomes & Findings for Post-Market Evaluation of the Rotation Medical Rotator Cuff System (NCT NCT02200939)

NCT ID: NCT02200939

Last Updated: 2022-03-02

Results Overview

The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).

Recruitment status

COMPLETED

Study phase

Target enrollment

148 participants

Primary outcome timeframe

Pre-operatively (baseline) to 3 month, 1 year, and 2 year

Results posted on

2022-03-02

Participant Flow

Recruitment started on 20 August 2014 and the study concluded on 24 November 2020 across 15 participating medical clinics in the United States.

Participant milestones

Participant milestones
Measure	Partial-Thickness Tear Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Full Thickness Tear Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair. Surgical repair: Surgical repair with commercially-available sutures/suture anchors.
Overall Study STARTED	33	115
Overall Study COMPLETED	31	104
Overall Study NOT COMPLETED	2	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Partial-Thickness Tear Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Full Thickness Tear Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair. Surgical repair: Surgical repair with commercially-available sutures/suture anchors.
Overall Study Participant withdrew consent	0	1
Overall Study Lost to Follow-up	2	9
Overall Study Subject moved out of town and unable to make it back to study	0	1

Baseline Characteristics

Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Partial-Thickness Tear n=33 Participants Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Full Thickness Tear n=115 Participants Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair. Surgical repair: Surgical repair with commercially-available sutures/suture anchors.	Total n=148 Participants Total of all reporting groups
Age, Continuous	54.60 years STANDARD_DEVIATION 10.13 • n=33 Participants	60.40 years STANDARD_DEVIATION 8.01 • n=115 Participants	59.10 years STANDARD_DEVIATION 8.83 • n=148 Participants
Sex: Female, Male Female	14 Participants n=33 Participants	39 Participants n=115 Participants	53 Participants n=148 Participants
Sex: Female, Male Male	19 Participants n=33 Participants	76 Participants n=115 Participants	95 Participants n=148 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	33 Participants n=33 Participants	100 Participants n=115 Participants	133 Participants n=148 Participants
Race/Ethnicity, Customized Ethnicity · Asian	0 Participants n=33 Participants	1 Participants n=115 Participants	1 Participants n=148 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	0 Participants n=33 Participants	5 Participants n=115 Participants	5 Participants n=148 Participants
Race/Ethnicity, Customized Ethnicity · African American	0 Participants n=33 Participants	9 Participants n=115 Participants	9 Participants n=148 Participants
Region of Enrollment United States	33 participants n=33 Participants	115 participants n=115 Participants	148 participants n=148 Participants
Hand Dominance Right	29 Participants n=33 Participants	103 Participants n=115 Participants	132 Participants n=148 Participants
Hand Dominance Left	4 Participants n=33 Participants	12 Participants n=115 Participants	16 Participants n=148 Participants
Affected Shoulder Right	17 Participants n=33 Participants	78 Participants n=115 Participants	95 Participants n=148 Participants
Affected Shoulder Left	16 Participants n=33 Participants	37 Participants n=115 Participants	53 Participants n=148 Participants
Smoking Habit Never Smoked	20 Participants n=33 Participants	81 Participants n=115 Participants	101 Participants n=148 Participants
Smoking Habit Former Smoker	12 Participants n=33 Participants	31 Participants n=115 Participants	43 Participants n=148 Participants
Smoking Habit Current Smoker	1 Participants n=33 Participants	3 Participants n=115 Participants	4 Participants n=148 Participants
Employment Status Currently employed (working for pay)	22 Participants n=33 Participants	83 Participants n=115 Participants	105 Participants n=148 Participants
Employment Status Currently unemployed (not working for pay)	11 Participants n=33 Participants	32 Participants n=115 Participants	43 Participants n=148 Participants
Tear Size: Partial-Thickness ONLY Grade 1: Low (< 3 mm)	0 Participants n=33 Participants • Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).	0 Participants Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).	0 Participants n=33 Participants • Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).
Tear Size: Partial-Thickness ONLY Grade 2: Intermediate (3-6 mm)	12 Participants n=33 Participants • Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).	0 Participants Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).	12 Participants n=33 Participants • Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).
Tear Size: Partial-Thickness ONLY Grade 3: High (> 6 mm)	21 Participants n=33 Participants • Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).	0 Participants Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).	21 Participants n=33 Participants • Full Thickness Tear not measured using this classification (i.e. measure applies to Partial-Thickness Tears only).
Tear Size: Full Thickness ONLY Small (< 1 cm)	0 Participants Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).	0 Participants n=115 Participants • Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).	0 Participants n=115 Participants • Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).
Tear Size: Full Thickness ONLY Medium (1-3 cm)	0 Participants Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).	66 Participants n=115 Participants • Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).	66 Participants n=115 Participants • Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).
Tear Size: Full Thickness ONLY Large (3-5 cm)	0 Participants Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).	49 Participants n=115 Participants • Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).	49 Participants n=115 Participants • Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).
Tear Size: Full Thickness ONLY Massive (> 5 cm)	0 Participants Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).	0 Participants n=115 Participants • Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).	0 Participants n=115 Participants • Partial-Thickness Tear not classified using this measurement (i.e. measure applies to Full Thickness Tears only).

PRIMARY outcome

Timeframe: Pre-operatively (baseline) to 3 month, 1 year, and 2 year

Population: Participants with partial-thickness or full thickness tears that provided data at the specified time frames.

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=21 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear n=58 Participants Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear n=38 Participants Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Change in Tendon Thickness Change from Baseline to 3 Month	1.7 millimeters Standard Deviation 1.5	2.6 millimeters Standard Deviation 19	1.2 millimeters Standard Deviation 1.7	1.2 millimeters Standard Deviation 2.2
Change in Tendon Thickness Change from Baseline to 1 Year	1.4 millimeters Standard Deviation 1.3	2.3 millimeters Standard Deviation 1.8	0.6 millimeters Standard Deviation 1.9	0.7 millimeters Standard Deviation 2.2
Change in Tendon Thickness Change from Baseline to 2 Year	1.2 millimeters Standard Deviation 1.3	1.8 millimeters Standard Deviation 2.2	0.7 millimeters Standard Deviation 2.0	0.7 millimeters Standard Deviation 2.3
Change in Tendon Thickness Change from 3 Months to 1 Year	-0.3 millimeters Standard Deviation 0.4	-0.4 millimeters Standard Deviation 0.6	-0.5 millimeters Standard Deviation 1.3	-0.4 millimeters Standard Deviation 1.9
Change in Tendon Thickness Change from 3 Months to 2 Year	-0.3 millimeters Standard Deviation 0.4	-0.8 millimeters Standard Deviation 1.2	-0.6 millimeters Standard Deviation 1.6	-0.6 millimeters Standard Deviation 1.8
Change in Tendon Thickness Change from 1 Year to 2 Year	-0.1 millimeters Standard Deviation 0.3	-0.4 millimeters Standard Deviation 0.9	-0.2 millimeters Standard Deviation 0.9	-0.1 millimeters Standard Deviation 1.1

PRIMARY outcome

Timeframe: 3 months, 1 year, and 2 years

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

Partial-thickness tears were classified as Intermediate (3-6 mm) or High (\> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions: 1. Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? 2. Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? 3. Was there evidence of bursitis in the shoulder? 4. Does the new tissue resemble normal tendon tissue? 5. Does the underlying tendon resemble normal tendon tissue? 6. Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=21 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear n=66 Participants Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear n=48 Participants Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Integration of Induced Tissue With Underlying Tendon 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? · Yes	2 Participants	0 Participants	8 Participants	2 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? · No	7 Participants	18 Participants	14 Participants	7 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? · Unable to determine	3 Participants	3 Participants	43 Participants	38 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? · No	5 Participants	11 Participants	5 Participants	5 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? · Unable to determine	7 Participants	9 Participants	60 Participants	43 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? · Yes	8 Participants	12 Participants	39 Participants	24 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? · No	1 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? · Yes	4 Participants	6 Participants	8 Participants	10 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? · No	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? · Unable to determine	8 Participants	15 Participants	57 Participants	38 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? · Yes	1 Participants	4 Participants	11 Participants	8 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? · No	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? · Unable to determine	10 Participants	16 Participants	51 Participants	32 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Was there evidence of bursitis in the shoulder? · No	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Was there evidence of bursitis in the shoulder? · No	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Was there evidence of bursitis in the shoulder? · Unable to determine	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Was there evidence of bursitis in the shoulder? · Yes	10 Participants	18 Participants	57 Participants	40 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Was there evidence of bursitis in the shoulder? · No	1 Participants	2 Participants	5 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Was there evidence of bursitis in the shoulder? · Unable to determine	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Does the new tissue resemble normal tendon tissue? · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Does the new tissue resemble normal tendon tissue? · No	12 Participants	21 Participants	65 Participants	45 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Does the new tissue resemble normal tendon tissue? · Unable to determine	0 Participants	0 Participants	1 Participants	2 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Does the new tissue resemble normal tendon tissue? · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Does the new tissue resemble normal tendon tissue? · Unable to determine	0 Participants	0 Participants	2 Participants	3 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Does the underlying tendon resemble normal tendon tissue? · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Does the underlying tendon resemble normal tendon tissue? · No	12 Participants	21 Participants	66 Participants	48 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Does the underlying tendon resemble normal tendon tissue? · No	12 Participants	21 Participants	66 Participants	48 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Does the underlying tendon resemble normal tendon tissue? · Unable to determine	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? · No	11 Participants	19 Participants	52 Participants	24 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? · Unable to determine	0 Participants	0 Participants	1 Participants	3 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Does the underlying tendon resemble normal tendon tissue? · Unable to determine	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Does the underlying tendon resemble normal tendon tissue? · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? · No	11 Participants	20 Participants	60 Participants	40 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: 3 Month: Does the underlying tendon resemble normal tendon tissue? · Unable to determine	0 Participants	0 Participants	2 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? · Yes	1 Participants	2 Participants	13 Participants	21 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? · Yes	4 Participants	9 Participants	43 Participants	29 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? · No	8 Participants	9 Participants	20 Participants	19 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? · No	2 Participants	7 Participants	2 Participants	2 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon? · Unable to determine	9 Participants	13 Participants	60 Participants	38 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid? · Unable to determine	3 Participants	9 Participants	26 Participants	23 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Was there evidence of bursitis in the shoulder? · Unable to determine	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 3 Month: Was there evidence of bursitis in the shoulder? · Yes	12 Participants	21 Participants	65 Participants	48 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Was there evidence of bursitis in the shoulder? · Yes	12 Participants	21 Participants	66 Participants	48 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? · Unable to determine	0 Participants	3 Participants	3 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? · Yes	6 Participants	10 Participants	49 Participants	22 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? · No	4 Participants	8 Participants	13 Participants	18 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)? · Unable to determine	1 Participants	2 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Does the new tissue resemble normal tendon tissue? · Yes	0 Participants	0 Participants	0 Participants	0 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Does the new tissue resemble normal tendon tissue? · No	12 Participants	21 Participants	65 Participants	43 Participants
Integration of Induced Tissue With Underlying Tendon 1 Year: Does the new tissue resemble normal tendon tissue? · Unable to determine	0 Participants	0 Participants	0 Participants	5 Participants
Integration of Induced Tissue With Underlying Tendon 2 Years: Does the new tissue resemble normal tendon tissue? · No	11 Participants	20 Participants	60 Participants	37 Participants

PRIMARY outcome

Timeframe: 3 months, 1 year, and 2 years

Population: Only participants with partial-thickness tears that provided data for the specified time frame. Participants with Full Thickness Tears were not assessed as data for this outcome measure can only be obtained from participants with a Partial-Thickness Tear (i.e., participants with full thickness tears cannot provide fill-in partial thickness tear information needed for this outcome).

For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as: * 0 to \<25% * 25% to \<50% * 50% to \< 75% * 75% to \< 100% * 100%

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=20 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 1 Year · 0 to < 25%	0 Participants	1 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 1 Year · 25% to < 50%	1 Participants	0 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 3 Months · 0 to < 25%	1 Participants	0 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 3 Months · 25% to < 50%	0 Participants	2 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 3 Months · 50% to < 75%	1 Participants	3 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 3 Months · 75% to < 100%	8 Participants	11 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 3 Months · 100%	2 Participants	4 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 1 Year · 50% to < 75%	2 Participants	3 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 1 Year · 75% to < 100%	7 Participants	10 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 1 Year · 100%	2 Participants	6 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 2 Years · 0 to < 25%	0 Participants	1 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 2 Years · 25% to < 50%	1 Participants	2 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 2 Years · 50% to < 75%	2 Participants	2 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 2 Years · 75% to < 100%	8 Participants	11 Participants	—	—
Fill-In of Partial Thickness Tears and Underlying Tendon Quality 2 Years · 100%	0 Participants	3 Participants	—	—

PRIMARY outcome

Timeframe: 3 months, 1 year, and 2 years

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=21 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear n=66 Participants Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear n=49 Participants Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Number of Participants With a Re-Tear 3 Months	0 Participants	1 Participants	3 Participants	10 Participants
Number of Participants With a Re-Tear 1 Year	0 Participants	1 Participants	7 Participants	12 Participants
Number of Participants With a Re-Tear 2 Years	0 Participants	1 Participants	7 Participants	14 Participants

SECONDARY outcome

Timeframe: Intraoperative

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=33 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=115 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Procedure Parameters: Device Implant Time	28.00 minutes Standard Deviation 16.65	10.50 minutes Standard Deviation 12.67	—	—

SECONDARY outcome

Timeframe: Intraoperative

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=33 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=115 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Procedure Parameters: Procedure Technical Success Device Implant Successful	33 Participants	115 Participants	—	—
Procedure Parameters: Procedure Technical Success Device Implant NOT Successful	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, 3 month, 1 year, and 2 years

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows: 1. ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better). 2. ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better). 3. ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better). Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=21 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear n=66 Participants Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear n=49 Participants Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
American Shoulder and Elbow Society (ASES) Score Baseline: Shoulder Function Score	15.3 score on a scale Standard Deviation 5.4	18 score on a scale Standard Deviation 8.5	15.9 score on a scale Standard Deviation 5.7	14.2 score on a scale Standard Deviation 6.4
American Shoulder and Elbow Society (ASES) Score 1 Year: Shoulder Function Score	27 score on a scale Standard Deviation 4	26.8 score on a scale Standard Deviation 6.8	27.8 score on a scale Standard Deviation 4.2	27.4 score on a scale Standard Deviation 5.8
American Shoulder and Elbow Society (ASES) Score 2 Years: Shoulder Function Score	27.7 score on a scale Standard Deviation 3.4	26.6 score on a scale Standard Deviation 9.1	27.9 score on a scale Standard Deviation 6.6	29.2 score on a scale Standard Deviation 1.9
American Shoulder and Elbow Society (ASES) Score Baseline: Shoulder Score	52.5 score on a scale Standard Deviation 13.6	60.9 score on a scale Standard Deviation 19.9	52.4 score on a scale Standard Deviation 18.3	48 score on a scale Standard Deviation 19
American Shoulder and Elbow Society (ASES) Score 3 Month: Shoulder Score	70.2 score on a scale Standard Deviation 18.6	78.9 score on a scale Standard Deviation 18.4	65.2 score on a scale Standard Deviation 19.6	67.9 score on a scale Standard Deviation 16.9
American Shoulder and Elbow Society (ASES) Score 2 Years: Shoulder Score	95.3 score on a scale Standard Deviation 5.8	92.8 score on a scale Standard Deviation 15.3	95.6 score on a scale Standard Deviation 13.2	96.3 score on a scale Standard Deviation 8.1
American Shoulder and Elbow Society (ASES) Score Baseline: ASES Pain Score	4.6 score on a scale Standard Deviation 1.9	4 score on a scale Standard Deviation 2.7	4.8 score on a scale Standard Deviation 2.3	5.2 score on a scale Standard Deviation 2.6
American Shoulder and Elbow Society (ASES) Score 3 Month: ASES Pain Score	1.8 score on a scale Standard Deviation 1.9	1.3 score on a scale Standard Deviation 1.6	1.8 score on a scale Standard Deviation 2.2	1.7 score on a scale Standard Deviation 2
American Shoulder and Elbow Society (ASES) Score 1 Year: ASES Pain Score	1.2 score on a scale Standard Deviation 1.6	0.2 score on a scale Standard Deviation 0.5	0.5 score on a scale Standard Deviation 1.2	0.5 score on a scale Standard Deviation 1.4
American Shoulder and Elbow Society (ASES) Score 2 Years: ASES Pain Score	0.2 score on a scale Standard Deviation 0.4	0.3 score on a scale Standard Deviation 0.7	0.2 score on a scale Standard Deviation 0.8	0.5 score on a scale Standard Deviation 1.2
American Shoulder and Elbow Society (ASES) Score 3 Month: Shoulder Function Score	17 score on a scale Standard Deviation 7	21.1 score on a scale Standard Deviation 8	14.6 score on a scale Standard Deviation 6.7	15.6 score on a scale Standard Deviation 7.2
American Shoulder and Elbow Society (ASES) Score 1 Year: Shoulder Score	89.2 score on a scale Standard Deviation 14.4	93.7 score on a scale Standard Deviation 11.7	94.3 score on a scale Standard Deviation 11.6	93.1 score on a scale Standard Deviation 13.2

SECONDARY outcome

Timeframe: Baseline, 3 months, 1 year, and 2 years

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=20 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear n=64 Participants Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear n=46 Participants Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Constant-Murley Shoulder (CMS) Score Baseline	51.6 score on a scale Standard Error 5.6	58.9 score on a scale Standard Error 19.6	51.2 score on a scale Standard Error 16.8	48.5 score on a scale Standard Error 18.1
Constant-Murley Shoulder (CMS) Score 1 Year	82.2 score on a scale Standard Error 10.4	85.6 score on a scale Standard Error 11.3	79.1 score on a scale Standard Error 11.8	85.3 score on a scale Standard Error 9.6
Constant-Murley Shoulder (CMS) Score 3 Months	51.5 score on a scale Standard Error 13.8	73.7 score on a scale Standard Error 15.2	63.2 score on a scale Standard Error 16.8	65.2 score on a scale Standard Error 14.7
Constant-Murley Shoulder (CMS) Score 2 Years	83.3 score on a scale Standard Error 9.9	93.8 score on a scale Standard Error 6	83.7 score on a scale Standard Error 9.5	84.4 score on a scale Standard Error 9.5

SECONDARY outcome

Timeframe: Post-operatively to study completion, approximately 2 years

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.

Cumulative number of days index shoulder was in a sling.

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=21 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear n=64 Participants Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear n=49 Participants Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Recovery: Sling Time	19.90 days Standard Deviation 9.39	26.60 days Standard Deviation 15.94	44.60 days Standard Deviation 43.23	39.20 days Standard Deviation 20.70

SECONDARY outcome

Timeframe: Post-operatively to study completion, approximately 2 years

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.

Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=19 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear n=60 Participants Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear n=47 Participants Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Recovery: Rehabilitation Time	14.30 days Standard Deviation 7.19	21.20 days Standard Deviation 11.08	22.50 days Standard Deviation 11.01	21.80 days Standard Deviation 14.44

SECONDARY outcome

Timeframe: Post-operatively to study completion, approximately 2 years

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.

Cumulative number of days between discharge and return to work (employed subjects only).

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=21 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear n=44 Participants Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear n=36 Participants Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Recovery: Return to Work	46.00 days Standard Deviation 62.99	58.80 days Standard Deviation 108.70	50.00 days Standard Deviation 72.93	66.50 days Standard Deviation 83.72

SECONDARY outcome

Timeframe: Post-operatively to study completion, approximately 2 years

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frame.

Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=21 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear n=62 Participants Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear n=45 Participants Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Recovery: Return to Normal Daily Activities	102.40 days Standard Deviation 99.95	147.30 days Standard Deviation 125.30	130.50 days Standard Deviation 64.45	130.90 days Standard Deviation 84.42

SECONDARY outcome

Timeframe: 3 months, 1 year, and 2 years

Population: Participants with partial-thickness tear or full thickness tear that provided data for the specified time frames.

Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following: * Strongly Disagree * Disagree * Neither Agree or Disagree * Agree * Strongly Agree "Strongly Disagree" indicated the lowest level of satisfaction and "Strongly Agree" indicated the greatest level of satisfaction.

Outcome measures

Outcome measures
Measure	Intermediate Partial-Thickness Tear n=12 Participants Intermediate partial-thickness tear (3-6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	High Partial-Thickness Tear n=20 Participants High partial-thickness tear (\> 6 mm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Medium Full Thickness Tear n=66 Participants Medium full thickness tear (1-3 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Large Full Thickness Tear n=49 Participants Large full thickness tear (3-5 cm) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.
Participant Satisfaction 3 Month · Strongly Disagree	0 Participants	0 Participants	0 Participants	1 Participants
Participant Satisfaction 1 Year · Agree	2 Participants	3 Participants	7 Participants	6 Participants
Participant Satisfaction 2 Year · Disagree	0 Participants	0 Participants	0 Participants	0 Participants
Participant Satisfaction 3 Month · Disagree	0 Participants	0 Participants	0 Participants	0 Participants
Participant Satisfaction 3 Month · Neither Agree or Disagree	2 Participants	3 Participants	4 Participants	2 Participants
Participant Satisfaction 3 Month · Agree	6 Participants	7 Participants	13 Participants	11 Participants
Participant Satisfaction 3 Month · Strongly Agree	4 Participants	10 Participants	49 Participants	35 Participants
Participant Satisfaction 1 Year · Strongly Disagree	0 Participants	0 Participants	1 Participants	2 Participants
Participant Satisfaction 1 Year · Disagree	0 Participants	0 Participants	1 Participants	0 Participants
Participant Satisfaction 1 Year · Neither Agree or Disagree	1 Participants	1 Participants	0 Participants	0 Participants
Participant Satisfaction 1 Year · Strongly Agree	9 Participants	16 Participants	57 Participants	40 Participants
Participant Satisfaction 2 Year · Strongly Disagree	1 Participants	1 Participants	1 Participants	1 Participants
Participant Satisfaction 2 Year · Neither Agree or Disagree	2 Participants	2 Participants	0 Participants	1 Participants
Participant Satisfaction 2 Year · Agree	1 Participants	1 Participants	3 Participants	0 Participants
Participant Satisfaction 2 Year · Strongly Agree	7 Participants	16 Participants	59 Participants	39 Participants

Adverse Events

Partial-Thickness Tear

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Full Thickness Tear

Serious events: 12 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Partial-Thickness Tear n=33 participants at risk Intermediate or High partial-thickness tear (PTT) or very small full-thickness tear (FTT) of the supraspinatus tendon surgically treated by implantation of the bioinductive implant.	Full Thickness Tear n=115 participants at risk Medium or large full thickness tear (FTT) of the supraspinatus tendon surgically treated with the bioinductive implant adjunctive to surgical repair. Surgical repair: Surgical repair with commercially-available sutures/suture anchors.
Cardiac disorders Cardiac Ablation	3.0% 1/33 • Number of events 1 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.	0.00% 0/115 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.
Musculoskeletal and connective tissue disorders Index shoulder new rotator cuff tear and lack of healing	0.00% 0/33 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.	0.87% 1/115 • Number of events 1 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.
Musculoskeletal and connective tissue disorders Contralateral shoulder distal clavical excision, RCT debridement of degenerative labrum & bursectomy	0.00% 0/33 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.	0.87% 1/115 • Number of events 1 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.
Musculoskeletal and connective tissue disorders Index shoulder recurrent rotator cuff tear	0.00% 0/33 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.	4.3% 5/115 • Number of events 5 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.
Musculoskeletal and connective tissue disorders Index shoulder recurrent full thickness rotator cuff tear	0.00% 0/33 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.	0.87% 1/115 • Number of events 1 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.
Injury, poisoning and procedural complications Foot Pain	0.00% 0/33 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.	0.87% 1/115 • Number of events 1 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.
Musculoskeletal and connective tissue disorders Contralateral Rotator Cuff Tear	0.00% 0/33 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.	0.87% 1/115 • Number of events 1 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.
Product Issues Index shoulder swelling and drainage	0.00% 0/33 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.	0.87% 1/115 • Number of events 1 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.
Product Issues Index shoulder pain, inflammatory changes, and osteopenia in the region of the greater tuberosity	0.00% 0/33 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.	0.87% 1/115 • Number of events 1 • Time of enrollment (i.e. intra-operative confirmation of eligibility) through end of the study (2 year follow-up visit). Only non-serious Adverse Events (AEs) classified by the Investigator as either device-related or procedure-related were to be reported, all Serious Adverse Events (SAEs) regardless of relationship to the device, and all Unanticipated Serious Adverse Device Effects (USADEs) were to be reported per protocol. However, all Serious \& Other AEs regardless of device/procedure relationship have been reported as provided. AEs were collected by investigator assessment, MRIs, and patient self-reporting.

Other adverse events

Additional Information

Laura England, Sr. Director Global Clinical Strategy

Smith+Nephew, Inc.

Phone: +1 650 223 6941

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee For multicenter studies the study data and results will be pooled and analyzed. If a multicenter publication is not submitted within 24 months after conclusion of study, site/investigator may publish individual results. Proposed publication must be submitted to sponsor no later than 90 prior to submission. Sponsor has right within 60 days to modify proposed publication if it will disclose patentable items.
Publication restrictions are in place

Restriction type: OTHER