Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation

Phase 4

Recruiting

• Conditions: Rotator Cuff Tears
• Interventions: Biological: Allograft Patch

• Registration Number: NCT04975581
• Lead Sponsor: University Hospitals, Leicester

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.

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 Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-23
• Study Start: 2021-12-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotator cuff repair surgery	Allograft Patch	Open Rotator cuff repair surgery
Rotator cuff repair Surgery with Augmentative patch	Allograft Patch	Open rotator cuff repair Surgery with additional application of augmentative human allograft patch

Primary Outcome Measures

Name	Time	Method
Retear on MRI scan	12-18 months

Trial Locations

Locations (1)

University Hopsitals of Leicester NHS Trust; 🇬🇧 Leicester, United Kingdom