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

The current study seeks to improve the management of patients suffering from massive irreparable rotator cuff tears. Despite several available surgical options, no level 1 evidence or randomized clinical trials have been performed in this patient population to date. Arthroscopic partial rotator cuff repair (PRCR) is arguably the gold-standard surgical option with the longest record of use. The new technique of superior capsular reconstruction (SCR) has also emerged with early biomechanical and case series showing promising results. SCR has quickly made its way into clinical practice in North America. Despite this, the effectiveness, cost, and safety profile has not been established for this procedure. As such, patients with massive irreparable rotator cuff tears are in need of high level evidence to support surgical decision making, particular with regards to the proliferation of SCR surgery.

This pilot study is a randomized, controlled, double-blinded trial comparing superior capsular reconstruction using dermal allograft with arthroscopic partial repair in patients with massive irreparable rotator cuff tears. In this study, "double-blind" includes study patients and outcome assessors. Randomization will occur intra-operatively once a tear is determined to be irreparable.

This trial will be conducted at 7 sites and involve 7 surgeons. Surgeons must meet eligibility requirements to participate (shoulder or sports fellowship-trained, minimum of 3 SCR procedures, and 25 arthroscopic rotator cuff repair procedures in the past year). A member of the local research team will pre-screen consults of eligible patients. Full eligibility will be determined during the primary appointment with an orthopaedic surgeon. Baseline data will be recorded following informed consent. Postoperative outcomes will be measured during regularly scheduled clinic visits (6 weeks, 3 months, 6 months, 1-year and 2-year post-surgery).

Prior to surgery, patients will have informed consent for both procedures, with randomization to be performed intraoperatively. Based on initial arthroscopic assessment of the shoulder, patients that have a confirmed irreparable tear will be randomized into one of two groups: arthroscopic partial repair or superior capsular reconstruction. Surgical techniques will be standardized. Allocation will be concealed using a centralized 24-hour computerized randomization system that will allow Internet-based allocation. A random number generator will be used to create a 1:1 allocation scheme for randomization of the patient into one of the two treatment groups. The post-operative therapy regimen will be the same for each group.

• Complication rate [Срок оценки: 1 year post operative]
• Recruitment rate [Срок оценки: 1 year post operative]
• Constant-Murley Score [Срок оценки: 1 year post operative]
• Western Ontario Rotator Cuff Index [Срок оценки: 1 year post operative]
• Pain: Numeric Rating Scale [Срок оценки: 1 year post operative]
• Range of Motion [Срок оценки: 1 year post operative]
• EQ-5D [Срок оценки: 1 year post operative]
• Xray: Acromio-Humeral Interval [Срок оценки: 1 year post operative]
• Xray: Degenerative Change [Срок оценки: 1 year post operative]
• MRI - graft healing [Срок оценки: 1 year post operative]
• MRI - tear size [Срок оценки: 1 year post operative]
• MRI - fatty degeneration [Срок оценки: 1 year post operative]