search
Back to results

Acellular Dermis in Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tears, Rotator Cuff Injuries

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
acellular dermis
Sponsored by
The Royal Orthopaedic Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring rotator cuff, shoulder, surgery, acellular dermal graft, acellular dermis, rotator cuff augmentation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Royal Orthopaedic Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

dermis group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

rotator cuff healing
Rotator cuff healing on MRI

Secondary Outcome Measures

Western Ontario Rotator cuff score
comparison of scores between groups
Constant Murley score
comparison of scores between groups
American shoulder and elbow surgeons standardized form
comparison of scores between groups

Full Information

First Posted
July 11, 2022
Last Updated
July 11, 2022
Sponsor
The Royal Orthopaedic Hospital NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT05458349
Brief Title
Acellular Dermis in Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 4, 2013 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Royal Orthopaedic Hospital NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Rotator Cuff Injuries
Keywords
rotator cuff, shoulder, surgery, acellular dermal graft, acellular dermis, rotator cuff augmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a Level 1 study, a prospective double blind, randomized controlled trial.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dermis group
Arm Type
Experimental
Arm Description
Group will receive standard of care treatment and interventions plus the use of the acellular dermal graft during surgery
Arm Title
control group
Arm Type
No Intervention
Arm Description
Group will receive standard of care treatment and interventions but the acellular dermal graft will not be used during surgery
Intervention Type
Device
Intervention Name(s)
acellular dermis
Primary Outcome Measure Information:
Title
rotator cuff healing
Description
Rotator cuff healing on MRI
Time Frame
12 month post-surgery
Secondary Outcome Measure Information:
Title
Western Ontario Rotator cuff score
Description
comparison of scores between groups
Time Frame
12months
Title
Constant Murley score
Description
comparison of scores between groups
Time Frame
12 months
Title
American shoulder and elbow surgeons standardized form
Description
comparison of scores between groups
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic rotator cuff tear that warrants operative intervention. A Tear measuring between 1-5cm at arthroscopy. An arthroscopic rotator cuff repair. Written consent. Exclusion Criteria: Rotator cuff tears greater than 5cm and less than 1cm Clinical or radiological evidence of osteoarthritis affecting the index side. Patients involved in a Compensation claim related to the shoulder. Inability to attend follow-up for 1 year and to a repeat MRI scan. Previous shoulder surgery or proximal humeral fracture on the index side. Patients that are recruited in a current study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martyn Mr Snow, MD
Organizational Affiliation
The Royal Orthopaedic Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Orthopaedic Hospital NHS Trust
City
Birmingham
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Acellular Dermis in Rotator Cuff Repair

We'll reach out to this number within 24 hrs