Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation

Sponsor
University Hospitals, Leicester
Study ID
NCT04975581
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Allograft Patch — BIOLOGICAL
    Rotator Cuff repair with Allograft Patch (Graftjacket Now)

Study Details

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.

Key Dates

First listed
Jul 23, 2021
Start date
Dec 3, 2021
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rotator cuff repair Surgery with Augmentative patch
    Open rotator cuff repair Surgery with additional application of augmentative human allograft patch
  • Active Comparator: Rotator cuff repair surgery
    Open Rotator cuff repair surgery

Primary Outcome Measure

Retear on MRI scan [ Time Frame: 12-18 months ]

Central Contacts

Related Studies