Acellular Dermis in Rotator Cuff Repair

The Royal Orthopaedic Hospital NHS Trust

Status: Completed

Conditions: Rotator Cuff Injuries; Rotator Cuff Tears

Treatments: Device: acellular dermis

Study type: Interventional

Funder types: Other

Identifiers

NCT05458349

ROH11ORTH09

Details and patient eligibility

About

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

Full 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

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups

dermis group

Experimental group

Description:

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

Treatment:

Device: acellular dermis

control group

No Intervention group

Description:

Group will receive standard of care treatment and interventions but the acellular dermal graft will not be used during surgery