Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation

NCT04975581 | Recruiting Phase 4 DMC

• 1 other identifier: EDGE ID 139197
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigators are planning to conduct a Pilot study of 40 patients of Pragmatic randomised controlled trial comparing rotator cuff tendons repair (small tendons around the shoulder ) with or without augmentative patch. It includes patients between age groups 50 to 75 years with large (≥ 3cm and \< 5 cm ) rotator cuff tear that can be fully repaired using open or mini open repair with or without an augmentation with a human dermal matrix allograft (processed skin graft from a human donor ). The main aim is to examine whether the addition of the patch helps to reduce the rate of re-tear of the rotator cuff tendons at one year following surgery. Patients are randomized to receive either a repair with addition of an augmentative patch or a repair without a patch and have an identical follow-up after surgery. Patients are followed up in outpatient at 6 weeks , 3 months and 12 months after randomization and receive an Magnetic Resonant Imaging (MRI) scan 12 months after surgery. The primary outcome measure is to assess the Re-tear rate of rotator cuff at 12 months after surgery. The secondary outcome measure is to assess functional scores of the shoulder at 12 months . The tertiary outcome measures are to check the cost effectiveness of each procedure.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Retear on MRI scan

  12-18 months

Study Arms (2)

Rotator cuff repair Surgery with Augmentative patch

EXPERIMENTAL

Open rotator cuff repair Surgery with additional application of augmentative human allograft patch

Biological: Allograft Patch

Rotator cuff repair surgery

ACTIVE COMPARATOR

Open Rotator cuff repair surgery

Biological: Allograft Patch

Interventions

Allograft Patch BIOLOGICAL

Rotator Cuff repair with Allograft Patch (Graftjacket Now)

Rotator cuff repair Surgery with Augmentative patch; Rotator cuff repair surgery

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged at least 50 years to 75 years.
• Degenerative cuff tear.
• Large Full thickness rotator cuff tear (≥ 3cm and \< 5 cm ) that is fully repairable.
• Tears diagnosed using MRI scan.
• Ability to consent.
• Agreement to use of human dermal matrix allograft as augmentative patch

You may not qualify if:

• Previous surgery on the affected shoulder.
• Osteoarthritic changes.
• Unable to have MRI Scans.
• Significant neck pathology.
• Cognitive problems or language issue.
• Systemic arthritis
• Significant dual pathology in the involved shoulder
• Acute Traumatic tears (\< 6 months since injury).

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

University Hopsitals of Leicester NHS Trust

Leicester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

UHL Sponsor

CONTACT

+44 116 258 8239 (1823); uhlsponsor@uhl-tr.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: July 23, 2021
• Study Start: December 3, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

GB (1)