nctId: NCT06289686 id: C.2023.080 briefTitle: MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation overallStatus: RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-05 name: Brooke Army Medical Center class: FED name: Sparta Biopharma name: Musculoskeletal Injury Rehabilitation Research for Operational Readiness briefSummary: 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 conditions: Rotator Cuff Injuries conditions: Surgery studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Rotator cuff repairs with BioEnthesis augmentation name: Rotator cuff repairs without BioEnthesis augmentation measure: Rates of re-tear measure: Change in the Visual Analogue Scale (VAS) from before surgery to after surgery measure: Change in the return to activities of daily living (ADL) from before surgery to after surgery measure: Change in the Concomitant medications (ConMeds) from before surgery to after surgery measure: Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery measure: Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery measure: Change in the Constant-Murley Score from before surgery to after surgery measure: Change in the shoulder immobilization status from before surgery to after surgery measure: Change in strength measurements from before surgery to after surgery measure: Change in range of motion measurements from before surgery to after surgery measure: Number of medical events/adverse events after surgery measure: Cumulative number of steroid injections after surgery measure: Number of unscheduled visits after surgery measure: Number of for-cause imaging procedures sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walter Reed National Military Medical Center status: NOT_YET_RECRUITING city: Bethesda state: Maryland zip: 20889 country: United States name: Kelly Kilcoyne, MD role: CONTACT phone: 301-295-2441 email: Kelly.G.Kilcoyne.mil@health.mil lat: 38.98067 lon: -77.10026 facility: Brooke Army Medical Center status: RECRUITING city: San Antonio state: Texas zip: 78234 country: United States name: Andrew Sheean, MD role: CONTACT phone: 210-916-1280 email: Andrew.J.Sheean.mil@health.mil lat: 29.42412 lon: -98.49363 hasResults: False