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