Recruiting

Superior Capsular Reconstruction vs. Partial Repair

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT03617562

Conditions

Rotator Cuff Tear

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Superior Capsular Reconstruction

Partial Repair

Study Details

Brief summary:

Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, its effectiveness, cost and safety profile have not been established.

The long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical trial.

Conditions

Rotator Cuff Tear

Study ID

NCT03617562

Start date

Jul 18, 2018

Status verified date

Jan, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Symptomatic shoulder pain and/ or weakness (regardless of baseline range of motion/ psuedoparalysis)
  • Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and infraspinatus.
  • Failure of at least a 3 month trial of non-surgical treatment including physiotherapy and activity modifications
  • Irreparable tear determined intra-operatively using standard arthroscopic techniques
  • Informed consent obtained

Exclusion Criteria:

  • Absence of subscapularis muscle insertion, or irreparable subscapularis tear
  • Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or glenohumeral osteoarthritis (Samilson-Prieto grade 2+)
  • Acute tears (within 6 months)
  • Neurologic injury causing paralysis of affected shoulder / arm
  • Any previous surgery to the affected shoulder
  • Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher)
  • Anticipated problems with ability to maintain follow-up in the judgement of the investigators (ie. patients with no fixed address, etc.)
  • Are there any non-orthopedic comorbidities that put the patient at significant risk?

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Superior Capsular Reconstruction

Patients will be treated with the new technique of superior capsular reconstruction with dermal allograft.

active comparator: Partial Repair

Patients will have a partial repair with residual defect as an established standard procedure.

Interventions

Superior Capsular Reconstruction

Residual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head.

Partial Repair

Rotator cuff is repaired with residual defect remaining.

Primary outcome measure

  • The American Shoulder and Elbow Surgeons Shoulder Score (ASES) [ Time Frame: 1 year post operative ]

Central Contacts and Locations

Central contacts

Patrick Henry, MD, FRCSC

416-967-8701patrick.henry@sunnybrook.ca

Ryan A Paul, MD, FRCSC

7808609272rpaul2011@gmail.com

Locations

Sunnybrook Holland Orthopaedic & Arthritic Centre

Recruiting

Toronto, Ontario, Canada, M4Y 1H1

Contacts

Patrick Henry, MD

416-967-8701patrick.henry@sunnybrook.ca

Ryan Paul, MD

7808609272rpaul2011@gmail.com

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contacts

Tim Dwyer, MD

tim.dwyer@wchospital.ca

research@utosm.com

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jul 30, 2026

Last verified

Jan, 2026

Keywords

  • Massive Rotator Cuff Tear
  • Shoulder Injuries

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-07-30.