Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique

Study Overview
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Brief Summary
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This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques. One technique used is the standard double row repairs utilizing medial and laterally based anchor fixation and the other technique is the standard double row repairs utilizing medial and laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is hypothesized that patients undergoing the surgery with the PRFM will report a higher quality of life than the patients that do not receive this treatment.

Official Title
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Arthroscopic Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique: A Randomized Blinded Outcomes Study

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Device: PRFM
* Procedure: Double Row


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of a rotator cuff tear as determined by clinical examination and diagnostic imaging (MRI) Patient undergoes arthroscopic rotator cuff repair Age 18 or older Exclusion Criteria: Pre-operative exclusion criteria Patient has had a previous arthroscopic rotator cut repair A previous diagnosis of Rheumatoid Arthritis Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous surgery of the affected shoulder, Evidence of significant rotator cuff arthropathy with superior humeral translation and acromial erosion diagnosed by x-ray or other investigations, Medical device that would exclude the patient from having a MRI, including a pacemaker, cardiac defibrillator, aneurysm clips, carotid artery clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, or ear implant. Major medical illness (life expectancy less then 2 years or unacceptably high operative risk), Inability to speak or read English Psychiatric illness that precludes informed consent. Pregnant patients. Age 17 or younger Unwillingness to be followed for 2 years. Bilateral Rotator cuff tear confirmed by clinical exam and MRI Patients enrolled in the study who demonstrate retear on clinical exam and MRI, then elect for a repeat surgery. Intra-operative exclusion criteria (Note: This information will be collected during the chart audit and patients will be excluded from the study at that time.) Irreparable cuff tears or tears extending into the subscapularis or teres minor Isolated teres minor or subscapularis tears. Inelastic and immobile tendon which cannot be advanced to articular margin

Ages Eligible for Study
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Minimum Age: 18 Years

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double Row<br>Double Row | Procedure: Double Row<br> <br> |
| Experimental: Double Row with PRFM<br>Double Row with PRFM | Device: PRFM<br> <br> Procedure: Double Row<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to Function | The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | Baseline | 
| Return to Function | The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study. | 6 months | 
| Return to Function | Western Ontario Rotator Cuff Index | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator cuff tear, Rotator cuff injury, Shoulder pain, Shoulder injury