Superior Capsule Reconstruction vs Partial Repair of Massive Rotator Cuff Tears (SCR)
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|ClinicalTrials.gov Identifier: NCT03617562|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : July 8, 2019
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, it's effectiveness, cost, and safety profile has 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.
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Procedure: Superior Capsule Reconstruction Procedure: Partial Repair||Not Applicable|
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 (3 months, 6 months, and 1-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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Arthroscopic Partial Repair vs. Superior Capsular Reconstruction for Massive Irreparable Rotator Cuff Tears: A Pilot Randomized Control Trial|
|Actual Study Start Date :||July 18, 2018|
|Estimated Primary Completion Date :||May 15, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Experimental: Superior Capsule Reconstruction
Patients will be treated with the new technique of superior capsule reconstruction with dermal allograft.
Procedure: Superior Capsule Reconstruction
Residual rotator cuff defect is reconstructed with a dermal allograft secured to the glenoid and humeral head.
Active Comparator: Partial Repair
Patients will have a partial repair with residual defect as an established standard procedure.
Procedure: Partial Repair
Rotator cuff is repaired with residual defect left remaining.
- The American Shoulder and Elbow Surgeons Shoulder Score (ASES) [ Time Frame: 1 year post operative ]
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)
- Complication rate [ Time Frame: 1 year post operative ]Incidence of minor and major complications related to each procedure.
- Recruitment rate [ Time Frame: 1 year post operative ]Assessment of number of eligible patients identified and number enrolled and randomized.
- Constant-Murley Score [ Time Frame: 1 year post operative ]
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.
- Western Ontario Rotator Cuff Index [ Time Frame: 1 year post operative ]
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.
- Pain: Numeric Rating Scale [ Time Frame: 1 year post operative ]Scale range: 0 to 10 (whole number integers). Higher scores represent more pain.
- Range of Motion [ Time Frame: 1 year post operative ]Measured by handheld goniometer
- EQ-5D [ Time Frame: 1 year post operative ]
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".
- Xray: Acromio-Humeral Interval [ Time Frame: 1 year post operative ]Measured distance from inferior acromion to superior humeral head at the closest distance. Distance in millimetres.
- Xray: Degenerative Change [ Time Frame: 1 year post operative ]
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
- MRI - graft healing [ Time Frame: 1 year post operative ]Assess graft integrity: Healed or Torn
- MRI - tear size [ Time Frame: 1 year post operative ]Assess size of recurrent tear (in maximum anterior to posterior and medial to lateral dimensions). Measured in cm.
- MRI - fatty degeneration [ Time Frame: 1 year post operative ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617562
|Contact: Patrick Henry, MD, FRCSCemail@example.com|
|Contact: Ryan A Paul, MD, FRCSCfirstname.lastname@example.org|
|Sunnybrook Holland Orthopaedic & Arthritic Centre||Recruiting|
|Toronto, Ontario, Canada, M4Y 1H1|
|Contact: Patrick Henry, MD 416-967-8701 email@example.com|
|Contact: Ryan Paul, MD 7808609272 firstname.lastname@example.org|
|Women's College Hospital||Recruiting|
|Toronto, Ontario, Canada, M5S 1B2|
|Contact: Tim Dwyer, MD email@example.com|
|Contact: Elyse Watkins firstname.lastname@example.org|
|Principal Investigator:||Patrick Henry, MD, FRCSC||Sunnybrook Health Sciences|