Acellular Dermis in Rotator Cuff Repair

Study Overview
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Brief Summary
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To determine if an acellular dermal graft (ADG) will incorporate into the rotator cuff and subsequently improve outcomes without an increase in risk to the patient

Detailed Description
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Rotator cuff healing poses a significant clinical problem with re-tear rates between 20-50%. The final functional outcome following surgery correlates with healing, with those that completely heal performing best. Failure of repair is mainly due to tendon failure both mechanically and biologically. If the healing and the structural properties of the tendon can be improved then significant functional gains may be achieved. This study will therefore utilise acellular dermal grafts to determine whether they could be used for to improve patient outcomes following surgery

Conditions
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Rotator Cuff Tears, Rotator Cuff Injuries

Intervention / Treatment
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* Device: acellular dermis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic rotator cuff tear that warrants operative intervention. A Tear measuring between 1-5cm at arthroscopy. An arthroscopic rotator cuff repair. Written consent. Exclusion Criteria: Rotator cuff tears greater than 5cm and less than 1cm Clinical or radiological evidence of osteoarthritis affecting the index side. Patients involved in a Compensation claim related to the shoulder. Inability to attend follow-up for 1 year and to a repeat MRI scan. Previous shoulder surgery or proximal humeral fracture on the index side. Patients that are recruited in a current study

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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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
Interventional Model Description: It is a Level 1 study, a prospective double blind, randomized controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dermis group<br>Group will receive standard of care treatment and interventions plus the use of the acellular dermal graft during surgery | Device: acellular dermis<br> <br> |
| No Intervention: control group<br>Group will receive standard of care treatment and interventions but the acellular dermal graft will not be used during surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rotator cuff healing | Rotator cuff healing on MRI | 12 month post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario Rotator cuff score | comparison of scores between groups | 12months | 
| Constant Murley score | comparison of scores between groups | 12 months | 
| American shoulder and elbow surgeons standardized form | comparison of scores between groups | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotator cuff, shoulder, surgery, acellular dermal graft, acellular dermis, rotator cuff augmentation