MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Brooke Army Medical Center
Study ID
NCT06289686
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Rotator Cuff Injuries
  • Rotator Cuff Tears
  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rotator cuff repairs with BioEnthesis augmentation — PROCEDURE
    Rotator cuff repair using BioEnthesis allograft patch
  • Rotator cuff repairs without BioEnthesis augmentation — PROCEDURE
    Rotator cuff repair using standard of care sutures and anchors

Study Details

Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.

Key Dates

Start date
Jul 31, 2024
Status verified
Jun 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: BioEnthesis
    Allogenic, acellular, biphasic allograft (BioEnthesis)
  • Active Comparator: Standard of Care
    Standard rotator cuff repair (suture and anchor based technique)

Primary Outcome Measure

Rates of re-tear [ Time Frame: Post-operation at 3-months, 6-months, and 12-months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889
Alfred Pisano, MD
[email protected]
301-295-2441
Brooke Army Medical CenterSan AntonioTexas78234
Andrew Sheean, MD
[email protected]
210-916-1280

Find similar trials in Bethesda, MD

By research site
Walter Reed National Military Medical Center· Bethesda, MDBrooke Army Medical Center· San Antonio, TX

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