Types of Fixation in Arthroscopic Rotator Cuff Repair

Study Overview
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Brief Summary
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The study will identify if there is a difference of quality of life after surgery between two techniques used in surgery. The two different techniques are either the Single Row Fixation or the Double Row Fixation.

Detailed Description
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Primary Research Question; What is the difference in disease specific quality of life between patients who undergo a repair of the rotator cuff with arthroscopic technique using single-row fixation, versus double-row fixation, as measured by the Western Ontario Rotator Cuff Index (WORC)at one year post op?

Official Title
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Single Row Versus Double Row Fixation in Arthroscopic Cuff Repair; a Randomized Controlled Sutdy.

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Procedure: single row
* Procedure: double row fixation


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. 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. Significant shoulder comorbidities Previous surgery on affected shoulder Patients with active workers compensation claims Active joint or systemic infection Significant muscle paralysis Rotatorcuff tear arthropathy Charcots arthropathy Major medical illness Unable to speak or read English Psychiatric illness that precludes informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: single row fixation<br> | Procedure: single row<br>* This method involves using a single row of anchor(s) to reattach the cuff to the bone.<br>|
| Active Comparator: double row fixation<br> | Procedure: double row fixation<br>* This technique, double row fixation, involves adding an extra anchor(s) over the number used for single row fixation. This extra anchor(s) is placed further inside the bone and may help to increase the fixation strength of the repair.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Rotator Cuff Index (WORC) | Do patients who undergo a repair of the rotator cuff with arthroscopic technique using double row fixation have increased disease specific quality of life (measured by WORC) then patients who undergo a repair with arthroscopic technique using single-row fixation? The WORC scale is from 0% to 100%, with a higher value being indicative of better disease specific quality of life. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Score | Differences in outcome between the two groups as measured by the Constant score. The constant score ranges from 1 to 100 with a higher value indicative of better shoulder function. | 2 Year | 
| ASES Score | Determination of differences in outcome between the two groups as measured by the American Shoulder and Elbow Surgeons (ASES) score. The ASES score ranges from 0 to 100 with a higher number indicative of better function. | 2 Year | 
| Strength Test | Shoulder strength in forward elevation was measured in kg using a portable scale. | 2 Years | 
| Healing Rate | Percentage of Participants who had healed by 1 year post-surgery as measured using magnetic resonance imaging. If the tendons were in continuity with no evidence of full-thickness tearing, the repair was considered healed (intact). | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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full thickness rotator cuff tear