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

Rotator Cuff Tear Clinical Trial

— SCR  

Official title:

Arthroscopic Partial Repair vs. Superior Capsular Reconstruction for Massive Irreparable Rotator Cuff Tears: A Pilot Randomized and Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03617562
• Other study ID #: SCR2018
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: July 2028

Study information

• Verified date: July 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Patrick Henry, MD, FRCSC
• Phone: 416-967-8701
• Email: patrick.henry[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2028
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Holland Orthopaedic & Arthritic Centre	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	St. Joseph's Healthcare Hamilton, The Ottawa Hospital, Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The American Shoulder and Elbow Surgeons Shoulder Score (ASES)	Functional Outcome Score; Sub scales: Pain (10 cm VAS); function/disability (10 items, each rated on 4-point Likert scale for level of difficulty); Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability)	1 year post operative
Secondary	Complication rate	Incidence of minor and major complications related to each procedure.	1 year post operative
Secondary	Recruitment rate	Assessment of number of eligible patients identified and number enrolled and randomized.	1 year post operative
Secondary	Constant-Murley Score	Functional outcome score; Sub scales: Pain item (4 Likert levels), Activities of Daily Living (Likert scales), Mobility (2 points for every 30 degrees of elevation), Strength (1 point per 0.5 kg); Score Range: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). Total score: 0-100. The higher the score, the higher the quality of the function.	1 year post operative
Secondary	Western Ontario Rotator Cuff Index	Functional outcome score; Consists of 21 visual analog scale (VAS) items organised in 5 subscales: physical symptoms, sports/recreation, work, lifestyle, and emotions.; Each item in WORC has a possible score from 0-100 (100mm VAS). Scores can be computed for individual subscales and summated for a total score, which can range from 0-2100, with a higher score representing lower quality of life.	1 year post operative
Secondary	Pain: Numeric Rating Scale	Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.	1 year post operative
Secondary	Range of Motion	Measured by handheld goniometer	1 year post operative
Secondary	EQ-5D	Health Related Quality of Life; The EQ-5D questionnaire is made up for two components; health state description and evaluation.; In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3.; Visual analogue scale: 20 cm vertical scale with end points of 0 and 100. 0 corresponds to " the worst health you can imagine", and 100 corresponds to "the best health you can imagine".	1 year post operative
Secondary	Xray: Acromio-Humeral Interval	Measured distance from inferior acromion to superior humeral head at the closest distance. Distance in millimetres.	1 year post operative
Secondary	Xray: Degenerative Change	Measured by Samilson-Prieto Grade: Mild Arthritis (Grade 1): inferior humeral and/or glenoid exostosis < 3mm in height; Moderate Arthritis (Grade 2): inferior humeral and/or glenoid exostosis measuring 3mm to 7mm slight gleno-humeral irregularity; Severe Arthritis (Grade 3): inferior humeral and/or glenoid exostosis measuring > 7mm gleno-humeral joint narrowing and sclerosis	1 year post operative
Secondary	MRI - graft healing	Assess graft integrity: Healed or Torn	1 year post operative
Secondary	MRI - tear size	Assess size of recurrent tear (in maximum anterior to posterior and medial to lateral dimensions). Measured in cm.	1 year post operative
Secondary	MRI - fatty degeneration	Measured by Goutallier classification of each rotator cuff muscle: grade 0: normal muscle grade 1: some fatty streaks grade 2: less than 50% fatty muscle atrophy grade 3: 50% fatty muscle atrophy grade 4: greater than 50% fatty muscle atrophy	1 year post operative