RecruitingPhase 4NCT04975581

Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation


Sponsor

University Hospitals, Leicester

Enrollment

40 participants

Start Date

Dec 3, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 75 Years

Inclusion Criteria6

  • 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

Exclusion Criteria8

  • 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).

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAllograft Patch

Rotator Cuff repair with Allograft Patch (Graftjacket Now)


Locations(1)

University Hopsitals of Leicester NHS Trust

Leicester, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04975581


Related Trials