Acellular Dermis in Rotator Cuff Repair

NCT05458349 | Completed

• 1 other identifier: ROH11ORTH09
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries

Keywords

rotator cuff; shoulder; surgery; acellular dermal graft; acellular dermis; rotator cuff augmentation

Outcome Measures

Primary Outcomes (1)

• rotator cuff healing

  Rotator cuff healing on MRI

  12 month post-surgery

Secondary Outcomes (3)

• Western Ontario Rotator cuff score

  12months

• Constant Murley score

  12 months

• American shoulder and elbow surgeons standardized form

  12 months

Study Arms (2)

dermis group

EXPERIMENTAL

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

Device: acellular dermis

control group

NO INTERVENTION

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

Interventions

acellular dermis DEVICE

dermis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic rotator cuff tear that warrants operative intervention.
• A Tear measuring between 1-5cm at arthroscopy.
• An arthroscopic rotator cuff repair.
• Written consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Orthopaedic Hospital NHS Trust: lead

Study Sites (1)

The Royal Orthopaedic Hospital NHS Trust

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Martyn Mr Snow, MD

  The Royal Orthopaedic Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a Level 1 study, a prospective double blind, randomized controlled trial.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: April 4, 2013
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)