Superior Capsule vs Bridging Study

Graft Reconstruction for Irreparable Rotator Cuff Tears: Superior Capsule Reconstruction or Tendon Repair With Graft Interposition

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04965103

Acronym

SCR

Enrollment

Registered

2021-07-16

Start date

2016-01-01

Completion date

2020-12-31

Last updated

2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears

Keywords

irreparable

Brief summary

Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in irreparable rotator cuff tears.

Detailed description

RCT n = 50 Groups: 1. bridging 2. SCR Outcomes: 1. WORC 2. ASES 3. QuickDASH 4. MRI at 12 months post-op

Interventions

PROCEDURESCR

Superior Capsule reconstruction

PROCEDUREBridging

Tendon repair with graft interposition

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Participant and research assistant collecting outcomes were blinded.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively) 2. Either primary tear or re-tear after previous repair 3. Radiographic evidence of Hamada stage 1-3, with or without Samilson & Prieto mild osteoarthritis (\<3mm inferior osteophyte)

Exclusion criteria

1. Primary glenohumeral osteoarthritis: radiographic evidence of Samilson & Prieto classification moderate or greater 2. Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above 3. Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis) 4. Medical issues precluding surgery 5. Unwilling or unable to complete study outcomes 6. Worker's Compensation Claim or litigation

Design outcomes

Primary

Measure	Time frame	Description
American Shoulder and Elbow Surgeon Outcome - patient portion	24 months	American Shoulder and Elbow Surgeon Outcome - patient portion (minimum score = 0, maximum score = 100, best outcome = 100)

Secondary

Measure	Time frame	Description
Western Ontario Rotator Cuff Index	24 months	Western Ontario Rotator Cuff Index (score converted to /100, minimum = 0, maximum = 100, best outcome = 100)
Disabilities of the Arm, Shoulder and Hand - QuickDASH	24 months	Disabilities of the Arm, Shoulder and Hand - QuickDASH (minimum = 100, maximum = 0, best outcome = 0)
Tendon healing, assessed via MRI	12 months	Tendon healing (classifications: intact or retorn)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026