NCT06289686

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Rotator Cuff Tears
• Rotator Cuff Injuries
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Rotator cuff repairs with BioEnthesis augmentation	Rotator cuff repair using BioEnthesis allograft patch
PROCEDURE	Rotator cuff repairs without BioEnthesis augmentation	Rotator cuff repair using standard of care sutures and anchors

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-03-04
• Last updated: 2024-06-07

Locations

2 sites across 1 country: United States