Acellular Dermis in Rotator Cuff Repair

NCT ID: NCT05458349

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-04

Study Completion Date

2021-02-11

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a Level 1 study, a prospective double blind, randomized controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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dermis group

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

Group Type EXPERIMENTAL

acellular dermis

Intervention Type DEVICE

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acellular dermis

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Royal Orthopaedic Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martyn Mr Snow, MD

Role: PRINCIPAL_INVESTIGATOR

The Royal Orthopaedic Hospital NHS Foundation Trust

Locations

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The Royal Orthopaedic Hospital NHS Trust

Birmingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ROH11ORTH09

Identifier Type: -

Identifier Source: org_study_id

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