Acellular Dermis in Rotator Cuff Repair

Not Applicable

Completed

• Conditions: Rotator Cuff Tears; Rotator Cuff Injuries
• Interventions: Device: acellular dermis

• Registration Number: NCT05458349
• Lead Sponsor: The Royal Orthopaedic Hospital NHS Trust

Brief Summary

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

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 Timeline

• Study Start: 2013-04-04
• Primary Completion: 2021-02-11
• Study Completion: 2021-02-11
• Status Verified: 2022-07
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-11
• Last Update Submitted: 2022-07-11
• Study First Posted: 2022-07-14
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dermis group	acellular dermis	Group will receive standard of care treatment and interventions plus the use of the acellular dermal graft during surgery

Primary Outcome Measures

Name	Time	Method
rotator cuff healing	12 month post-surgery	Rotator cuff healing on MRI

Secondary Outcome Measures

Name	Time	Method
Western Ontario Rotator cuff score	12months	comparison of scores between groups
Constant Murley score	12 months	comparison of scores between groups
American shoulder and elbow surgeons standardized form	12 months	comparison of scores between groups

Trial Locations

Locations (1)

The Royal Orthopaedic Hospital NHS Trust; 🇬🇧 Birmingham, United Kingdom