Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation (CUFFPATCH)

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Biological: Allograft Patch

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: UHL Sponsor; Phone Number: +44 116 258 8239 (1823); Email: uhlsponsor@uhl-tr.nhs.uk

Study Locations

• United Kingdom
  • Leicester, United Kingdom
    • Recruiting
    • University Hopsitals of Leicester NHS Trust
    • Contact: UHL Sponsor; Phone Number: +44 116 258 8239(1823)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotator cuff repair Surgery with Augmentative patch; Open rotator cuff repair Surgery with additional application of augmentative human allograft patch	Biological: Allograft Patch; Rotator Cuff repair with Allograft Patch (Graftjacket Now)
Active Comparator: Rotator cuff repair surgery; Open Rotator cuff repair surgery	Biological: Allograft Patch; Rotator Cuff repair with Allograft Patch (Graftjacket Now)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Retear on MRI scan	12-18 months

Collaborators and Investigators

• Sponsor: University Hospitals, Leicester

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: EDGE ID 139197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No