Acellular Dermis in Rotator Cuff Repair

The Royal Orthopaedic Hospital NHS Trust63 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rotator Cuff Tears Rotator Cuff Injuries

Interventions

acellular dermisDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Symptomatic rotator cuff tear that warrants operative intervention. 2. A Tear measuring between 1-5cm at arthroscopy. 3. An arthroscopic rotator cuff repair. 4. Written consent. Exclusion Criteria: 1. Rotator cuff tears greater than 5cm and less than 1cm 2. Clinical or radiological evidence of osteoarthritis affecting the index side. 3. Patients involved in a Compensation claim related to the shoulder. 4. Inability to attend follow-up for 1 year and to a repeat MRI scan. 5. Previous shoulder surgery or proximal humeral fracture on the index side. 6. Patients that are recruited in a current study

Locations (1)

The Royal Orthopaedic Hospital NHS Trust

Birmingham, United Kingdom

Outcomes

Primary Outcomes

rotator cuff healing

Rotator cuff healing on MRI

Time frame: 12 month post-surgery

Secondary Outcomes

Western Ontario Rotator cuff score

comparison of scores between groups

Time frame: 12months

Constant Murley score

comparison of scores between groups

Time frame: 12 months

American shoulder and elbow surgeons standardized form

comparison of scores between groups

Time frame: 12 months

Data from ClinicalTrials.gov

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