Acellular Dermis in Rotator Cuff Repair

July 11, 2022 updated by: The Royal Orthopaedic Hospital NHS Trust
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • The Royal Orthopaedic Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dermis group
Group will receive standard of care treatment and interventions plus the use of the acellular dermal graft during surgery
Device: acellular dermis
No Intervention: control group
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?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Royal Orthopaedic Hospital NHS Trust

Investigators

  • Principal Investigator: Martyn Mr Snow, MD, The Royal Orthopaedic Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2013

Primary Completion (Actual)

February 11, 2021

Study Completion (Actual)

February 11, 2021

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROH11ORTH09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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