Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

Study Overview
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Brief Summary
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This Clinical Trial is being conducted to study an adjunctive treatment for rotator cuff repair; bone trephination.Trephination is a procedure that involves making small perforations in the bone that the tendon is repaired to.The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon. The control group will undergo the standard repair for rotator cuff tears. It is the investigators' hypothesis that healing rates in patients who undergo bone trephination will be higher compared with surgery without trephination in arthroscopic rotator cuff repair at 24 months post-operatively.

Detailed Description
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Rotator cuff repair carried out with current techniques has shown favourable results in terms of pain relief. However the re-tear rates remain high and are associated with significant morbidity in terms of functional outcome and shoulder strength. As rotator cuff disease becomes ever more prevalent with our aging population, it is imperative to determine if healing rates can be improved with autologous stem cell enhancement with pre-surgical preparation of the tendon insertion site through trephination. This trial is necessary both to provide optimal care of our patients, and to do so in a fiscally responsible fashion. The primary outcome measure the re-tear rate as measured by ultrasound at 24 months post-operatively. The secondary outcome measures are Western Ontario Rotator Cuff Index (WORC), Constant Score, and the American Shoulder and Elbow surgeons standardized assessment of shoulder function (ASES).

Official Title
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Trephination in Arthroscopic Cuff Repair: a Prospective Randomized Controlled

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Procedure: Bone Trephination
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as: The use of drugs including analgesics and non-steroidal anti-inflammatory drugs Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc) Activity modification Imaging, and intra-operative findings confirming a full thickness tear of the rotator cuff. Exclusion Criteria: Characteristics of the cuff tear that render the cuff irrepairable: fatty infiltration in the muscles grade III (50%) or greater; superior subluxation of the humeral head; retraction of the cuff to the level of the glenoid rim. Partial thickness cuff tears. Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis Previous surgery on affected shoulder e.g. Previous rotator cuff repair. Isolated subscapularis tendon tears Active joint or systemic infection Significant muscle paralysis Rotator cuff tear arthropathy Charcot's arthropathy Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica) Major medical illness (life expectancy less then 1 year or unacceptably high operative risk) Unable to speak or read English/French Psychiatric illness that precludes informed consent Unwilling to be followed for 24 months Advanced physiologic age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bone Trephination<br>For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus. | Procedure: Bone Trephination<br>* For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.<br>Procedure: Control<br>* The control group will undergo standard rotator cuff repair.<br>|
| Active Comparator: Control<br>The control group will undergo standard rotator cuff repair. | Procedure: Control<br>* The control group will undergo standard rotator cuff repair.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High-resolution ultrasound | High-resolution ultrasound will be used as the primary outcome measure to determine the re-tear rate at 6 and 24 months following repair. Ultrasound was chosen as it has been shown to have a high degree of accuracy for the diagnosis of rotator tears that is equivalent but less expensive than MRI. The interpretation of the high-resolution ultrasound is based on healing status and will be carried out by a trained MSK radiologist. Healing status will be documented at both 6 and 24 months as either completely healed, partially healed, or not healed. For tendons partially healed or not healed, the size of the defect will be compared with the size of the tear pre-operatively. | 6 and 24 months post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Outcome scores | WORC, ASES and Constant | baseline and 3, 6, 12, 18 and 24 months post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cuff repair, arthroscopic, Trephination, Bone, cuff tear