Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSunnybrook Health Sciences Centre

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Superior Capsular Reconstruction
  • Partial Repair

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sunnybrook Health Sciences Centre

Lead sponsor

Women's College Hospital

Collaborator

St. Joseph's Healthcare Hamilton

Collaborator

The Ottawa Hospital

Collaborator