Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation

Rotator Cuff Tears Clinical Trial

— CUFFPATCH  

Official title:

Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04975581
• Other study ID #: EDGE ID 139197
• Status: Recruiting
• Phase: Phase 4
• Start date: December 3, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: University Hospitals, Leicester
• Contact: UHL Sponsor
• Phone: +44 116 258 8239 (1823)
• Email: uhlsponsor[@]uhl-tr.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Biological:
• Allograft Patch
Rotator Cuff repair with Allograft Patch (Graftjacket Now)

Locations

Country	Name	City	State
United Kingdom	University Hopsitals of Leicester NHS Trust	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retear on MRI scan		12-18 months