[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Brooke Army Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":244},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,76,103,126,153,176,205,229],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053385","phase-4-rotator-cuff-repairs-with-or-without-bioenthesis-augmentation-100053385",false,"NCT06289686","Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation","Inclusion Criteria:\n\n* DEERS-eligible\n* Adults, between the ages of 18-65 (inclusive)\n* Presenting with a rotator cuff tear that is reparable surgically (a reparable tear is defined as tear of the RC where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension)\n* Ability to undergo surgery to repair rotator cuff tear\n* Willingness to commit to study procedures including study intervention and a 12-month follow-up\n* Fluency in speaking, reading, comprehending English\n* 1-2 tendon full thickness reparable RC tear (full thickness tear is defined as a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border)\n* Patients who have high-grade partial thickness tears where the surgeon elects to complete the tear during surgery before repairing the tendon(s)\n\nExclusion Criteria:\n\n* Previous shoulder surgery (excluding acromioplasty or diagnostic arthroscopy)\n* Inability to receive an MRI\n* Current (within the past 6 months) tobacco user\n* Unwilling to remain tobacco free for the duration of the study\n* Current lower limb injuries requiring walking assist devices such as crutches and walkers\n* Diagnosed with systemic arthritis\n* Significant neck pathology\n* Active joint or systemic infection\n* Currently enrolled, or plans to enroll, in another clinical trial during this study (that would affect the patient's safety or results of this trial)\n* Significant muscle paralysis of the shoulder girdle\n* Currently pregnant or plans to become pregnant during this study\n* Inability of the surgeon to repair the tear with remaining defect no greater than 10 mm in diameter\n* Inability of the surgeon to repair the tear with less than 1cm of medialization\n* Evidence of other significant shoulder pathology (such as Grade III osteoarthritis)\n* Has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction\n* Major medical illness that would preclude undergoing surgery\n* Major psychiatric illness or developmental handicap\n* Goutallier III classification and above","ALL","18 Years","65 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","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.",[26,27,28],"Rotator Cuff Tears","Rotator Cuff Injuries","Surgery","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2023-07-28",{"date":37,"type":20},"2027-08",{"name":39,"class":40},"Brooke Army Medical Center","FED",5,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":41},"100588406","the-promoting-pain-self-management-pros-trial-holistic-pain-care-in-the-military-health-system-100588406","NCT06940986","The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System","PROs","Inclusion Criteria:\n\n* Age 18 or older\n* TRICARE Beneficiary\n* Meets the case definition of chronic MSK pain requiring 2 or more medical encounters within the past year and at least 90 days apart for the same MSK condition indicated by medical encounter data or MSK pain ICD-10 codes in the electronic medical record\n\nExclusion Criteria:\n\n* Actively receiving cancer treatment\n* Currently known to be pregnant\n* Receiving advanced chronic pain management, including multi-disciplinary or behavioral pain management or mental health or substance use programs (beyond the initial step of the VA\u002FDoD stepped care model for pain management)\n* Suicidal Ideation determined by a higher than lower risk score on the P4 Screener\n* Currently undergoing post-surgical rehabilitation",{"count":50,"type":20},608,[52],"NA","The goal of this study is to improve pain care in the MHS by identifying effective, whole-person, non-pharmacologic interventions for persons with chronic musculoskeletal pain. The investigators will evaluate two promising, evidence-based holistic health interventions and compare them to usual care.",[55,56,57],"Chronic Pain","Musculoskeletal Pain","Musculoskeletal Pain Disorder",[59,60,61,62,63,64,65,66,67],"Empowered Relief","Move to Health","Holistic Pain Care","stepped care","chronic musculoskeletal pain","self-management","pain management","military","holistic health","2026-05-21",{"date":70,"type":33},"2026-05-26",{"date":72,"type":33},"2025-12-19",{"date":74,"type":20},"2028-07-01",{"name":39,"class":40},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100557931","is-conditioned-pain-modulation-predictive-of-clinical-improvement-in-patients-with-chronic-low-back-pain-100557931","NCT06544525","Is Conditioned Pain Modulation Predictive of Clinical Improvement in Patients With Chronic Low Back Pain?","Inclusion Criteria:\n\n* DEERS eligible\n* English speaking\n* Age 18-64 years\n* ODI baseline ≥25%\n* NPRS baseline ≥3\u002F10\n* Low back pain symptoms greater than 3 months\n* Must be able to commit to at least six weeks of physical therapy interventions\n\nExclusion Criteria:\n\n* Serious spinal pathology (acute fracture, active cancer, inflammation, inflammatory arthropathy)\n* Low back pain symptoms radiating below the knee\n* Pregnancy\n* Diagnosed neurological disease including traumatic brain injury, multiple sclerosis, chronic regional pain syndrome, and fibromyalgia.\n* History spinal surgery\n* Currently under litigation related to low back pain\n* Currently going through Medical Evaluation Board (MEB)\n* Retiring or separating from the military within a year","64 Years",{"count":84,"type":20},57,[52],"Conditioned pain modulation (CPM) a measure of the effectiveness of the descending pain pathway and therefore a measure of the body's ability to perform endogenous analgesia. In subjects with normal function of the descending pain pathway, the net-effect during CPM testing is anti-nociceptive, or inhibition of the ascending pain pathway. In those with impaired descending pain pathway function, the response to CPM testing is pro-nociceptive, indicating that the body is unable to inhibit the pain signal, or may even amplify it. There is literature that supports the presence of impaired CPM, and therefore impaired descending pain pathway function, in numerus chronic pain conditions, including low back pain. Impaired descending pain pathway function may be contributing to this chronic pain presentation. This study will give us information on whether a typical physical therapy plan of care is able to improve impaired CPM, and if CPM values are predictive of improvement in physical therapy.",[88],"Low Back Pain",[90,91,92,93],"low back pain","physical therapy","conditioned pain modulation","temporal summation","2025-04-22",{"date":96,"type":33},"2025-04-23",{"date":98,"type":33},"2024-09-19",{"date":100,"type":20},"2025-07",{"name":39,"class":40},1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100569873","antibiotic-concentrations-after-massive-transfusion-study-100569873","NCT06699901","Antibiotic Concentrations After MassivE Transfusion Study","Antibiotic Concentrations After MassivE Transfusion (ACME) Study","ACME","Inclusion Criteria:\n\n* Receives ampicillin\u002Fsulbactam, cefazolin, cefepime, ceftriaxone, clindamycin, ertapenem, levofloxacin, metronidazole or pipercillin\u002Ftazobactam at any dose\n* Hospitalized or anticipated hospital admission\n\nExclusion Criteria:\n\n* Received the same antibiotic within the past 5 half-lives of the drug (e.g. received the same antibiotic during a recent interval)\n* \\\u003C18 years of age\n* Known pregnancy\n* Known Prisoner",{"count":112,"type":20},417,"OBSERVATIONAL","Combat and civilian trauma frequently result in open wounds that are at risk for infection. Data from the Department of Defense Trauma Registry demonstrate that 74% of combat trauma casualties have an open wound. The Committee on Tactical Combat Casualty Care, the Prolonged Field Care Working Group, and the Joint Trauma System clinical practice guidelines recommend antibiotic prophylaxis for open wounds after trauma. The civilian setting has similar risks of open wound infection after trauma. In parallel, current practice guidelines recommend the aggressive use of balanced blood products during resuscitation. It remains unclear how the replacement of blood after hemorrhage through transfusion may affect antibiotic concentrations. Data is necessary to better understand this relationship to enhance wound prophylaxis antibiotic dosing, particularly in severely wounded casualties who receive blood products during massive transfusions. It remains unclear how these resuscitation methods may alter pharmacokinetics. The investigators hypothesize that drug concentrations decrease in direct relation to the amount of blood transfused during low-volume, massive, and supermassive transfusion after trauma compared to patients who receive no blood products. The investigators seek to understand the relationship between drug concentrations and blood product administration using a non-compartmentalized model in the setting of hemorrhage. Specifically, they will (1) obtain drug concentrations at regular intervals during the first 12-18 hours after administration of antibiotics, (2) determine how much blood products and fluids are transfused during the 12 hours prior to antibiotic and 24 hours post-administration, and (3) perform data modeling to understand the relationship between blood transfusions and drug concentrations to inform data-driven dosing models. Liquid chromatography methods will be developed to measure drug concentrations. The investigators will conduct a prospective, multicenter study at two large trauma centers - Brooke Army Medical Center and the University of Colorado Hospital. They will seek to enroll any participant who is hospitalized or anticipated hospital admission for acute trauma and receives an antibiotic on the study list during their index hospitalization. They will then model the drug levels against the amount of blood and fluid infused to create an understanding of the pharmacokinetics of antibiotic wound prophylaxis.",[116],"Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Affecting Blood Constituents","2025-02-07",{"date":119,"type":33},"2025-02-11",{"date":121,"type":33},"2024-09-30",{"date":123,"type":20},"2027-09-30",{"name":39,"class":40},2,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":102},"100562377","the-effect-of-manual-physical-therapy-and-exercise-in-addition-to-routine-dental-care-in-individuals-with-temporomandibular-disorders-100562377","NCT06602375","The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals With Temporomandibular Disorders","The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals With Temporomandibular Disorders: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Active-Duty Service Members\n* Complaint of TMD symptoms\n* Must be able to be followed for twelve weeks after consent\n* TMD Screener score ≥ 3 45\n\nExclusion Criteria:\n\n* Actively in a Trainee status\n* Utilized oral device in past 6 months\n* Facial injection therapy in the prior 6 months\n* Facial surgery in the preceding 6 months\n* Serious spinal pathology (acute fracture, active cancer, instability)\n* Diagnosed neurological or rheumatological disease\n* Currently under litigation related to temporomandibular or cervical spine pain(s)\n* Currently undergoing Medical Evaluation Board (MEB)\n* Retiring or separating from the military within a year","55 Years",{"count":135,"type":20},60,[52],"The goal of this randomized clinical trial among US military active-duty service-members with temporomandibular disorders (TMD) is to determine whether standard care plus 6-weeks of tailored, individualized physical therapy (PT) treatment provides greater benefit than standard care alone in patient-reported outcomes, and maximal mouth opening.\n\nThe aims of the study are to compare outcomes in individuals with TMD that receive standard care treatment versus standard care plus PT interventions at 0-, 6-, and 12-weeks. The investigators anticipate that subjects in the standard care plus PT group will exhibit improved patient-reported outcomes, and maximal mouth opening compared to those who received standard care alone.\n\nAdditionally, the investigators will compare the amount and type of healthcare utilization between the two groups (Standard Care and Standard Care + PT) in the 12-month period following enrollment in the study.\n\nAll participants will be managed by their primary dental provider and receive care as deemed appropriate by their provider. All participants will complete patient-reported outcome measures and have their jaw motion measured. Those randomized to the standard care plus PT group will also receive a tailored PT evaluation followed by an individualized plan of care two times per week for up to six weeks.",[139],"Temporomandibular Disorders (TMD)",[141,142,143,144],"Temporomandibular Disorders","Physical Therapy","Manual Therapy","Exercise","2025-02-03",{"date":147,"type":33},"2025-02-05",{"date":149,"type":33},"2024-09-16",{"date":151,"type":20},"2026-06-30",{"name":39,"class":40},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":175,"locationsCount":102},"100558374","small-nerve-fiber-activity-in-patients-with-carpal-tunnel-syndrome-assessed-via-quantitative-sensory-testing-100558374","NCT06550284","Small Nerve Fiber Activity in Patients with Carpal Tunnel Syndrome Assessed Via Quantitative Sensory Testing","Inclusion Criteria:\n\nDEERS eligible Age 18-65 Pain and paresthesia in the median nerve distribution A positive Phalen test A positive Tinel test over the carpal tunnel Willing to attend physical therapy\n\nExclusion Criteria:\n\nNerve root signs consistent with a radiculopathy Suspected radial and ulnar nerve involvement based on monofilament testing Bilateral CTS Previous hand surgery Injections in the upper quarter in the last 6 months Cervical, shoulder, or UE trauma in the last 6 months Currently pregnant or postpartum within the last 6 months No more than minimal care (evaluation and patient education, 1 visit) for the current episode",{"count":160,"type":20},48,[52],"The diagnosis of carpal tunnel syndrome (CTS) is typically based on clinical findings and confirmatory electrodiagnostic testing. However, electrodiagnostic testing can only assess large A-alpha and A-beta nerve fibers. Quantitative sensory testing (QST) is a series of tests used to assess small nerve fiber changes in the A-delta, c-fibers, and A-beta nerve fibers as well. Previous studies have used QST to assess small nerve fiber changes related to carpal tunnel syndrome and found changes compared to controls. This study will utilize a course of standard physical therapy care and assess for any changes to small nerve fiber activity and how those changes may or may not relate to patient outcomes.",[164],"Carpal Tunnel Syndrome",[166,167,168,169,170],"carpal tunnel syndrome","quantitative sensory testing","median nerve","neuropathy","small nerve fiber",{"date":147,"type":33},{"date":173,"type":33},"2024-11-12",{"date":100,"type":20},{"name":39,"class":40},{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":183,"sex":184,"minAge":16,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":102},"100559135","orthopaedic-manual-physical-therapy-as-part-of-the-postpartum-care-continuum-100559135","NCT06560190","Orthopaedic Manual Physical Therapy as Part of the Postpartum Care Continuum","Orthopaedic Manual Physical Therapy as Part of the Postpartum Care Continuum for Active-Duty Service Members","Inclusion Criteria:\n\n* Female Active-Duty Service Member\n* Postpartum \\>6 weeks and \\\u003C6 months\n* Cleared by OBGYN at postpartum follow-up to initiate physical activity\n\nExclusion Criteria:\n\n* Current or ongoing treatment by an orthopaedic physical therapist\n* Separating from military service in the next 6 months\n* Current permanent profile for a musculoskeletal condition\n* Peripartum Hysterectomy",true,"FEMALE","44 Years",{"count":187,"type":20},58,[52],"Data shows us that injury risk increases in the first year postpartum. There is a paucity of literature regarding MSK injuries in postpartum military women. A unique challenge that postpartum service members face is the increased stress of training for and having to pass a physical fitness test directly tied to their career advancement.\n\nWhile there is epidemiological data across multiple branches of service, there is a gap in the literature in terms of how to appropriately address these decreased fitness levels and better understand the root causes. American College of Gynecology (ACOG) recommends that the postpartum visit include actionable information on return to physical activity. However, a large majority of women report receiving no guidance on how to engage in physical activity during pregnancy and in the postpartum period.\n\nPhysical therapy is commonly used to help individuals return to physical activity following orthopaedic surgeries, but it is not frequently utilized to assist the postpartum population in progressing back to physical activity. Orthopaedic Manual Physical Therapists (OMPTs) are uniquely trained to address musculoskeletal symptoms and progress physical activity. An OMPT evaluation and treatment could facilitate increased physical activity and improve health-related quality of life, supporting the ACOG recommendation to make postpartum care an ongoing multidisciplinary process.",[191,192],"Postpartum","Pregnancy Related",[191,194,195,196,142],"Physical Activity","Pregnancy","Service Member","2024-08-19",{"date":199,"type":33},"2024-08-21",{"date":201,"type":33},"2024-04-08",{"date":203,"type":20},"2025-07-05",{"name":39,"class":40},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":82,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":220,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":4},"100558677","the-influence-of-an-orthopaedic-manual-physical-therapy-and-sensory-training-on-somatoperception-in-patients-with-chronic-low-back-pain-100558677","NCT06554236","The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain","The Influence of an Orthopaedic Manual Physical Therapy Approach and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain","Inclusion Criteria:\n\n* DEERS eligible\n* 18 to 64 years old\n* Low back pain \\> 3 months\n* Numeric Pain Rating Scale minimal pain rating of 3\u002F10 in the last seven days\n* Must be able to commit to 6-10 treatment sessions over a period of at least 6-we\n\nExclusion Criteria:\n\n* History of spinal surgery\n* History of spinal injections or nerve ablations in the past year\n* History of traumatic brain injury (TBI)\n* History of cerebral vascular accident (CVA)\n* Currently pregnant\n* Active cancer\n* Symptoms below the knee\n* Non-MSK condition contributing to low back pain\n* Chronic Pain Conditions to include Chronic Regional Pain Syndrome and Fibromyalgia\n* Autoimmune Diseases (to include Ankylosing Spondylitis, Lupus, Rheumatoid Arthritis)\n* Currently under litigation related to low back pain\n* Currently going through Medical Evaluation Board (MEB)\n* Retiring or separating from the military within a year\n* Currently receiving physical therapy for low back pain",{"count":160,"type":20},[52],"Individuals with chronic low back pain and other chronic pain conditions have been shown to have altered somatosensory, the ability to sense input to the tissue, which is processed in the primary somatosensory cortex or S1. Two-point discrimination is currently the best clinical tool utilized to assess an individual's ability to sense touch. This study will assess TPD changes after a course of standard physical therapy care with the addition of sensory training.",[88],[217,91,218,219],"two-point discrimination","somatoperception","tactile acuity","NOT_YET_RECRUITING","2024-08-13",{"date":223,"type":33},"2024-08-15",{"date":225,"type":20},"2024-08-31",{"date":227,"type":20},"2025-06",{"name":39,"class":40},{"id":230,"slug":4,"hasResults":11,"nctId":12,"briefTitle":231,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":234,"briefSummary":24,"conditions":235,"keywords":4,"overallStatus":220,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":125},"100538350","MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation","Inclusion Criteria:\n\n* DEERS-eligible\n* Adults, between the ages of 18-65 (inclusive)\n* Presenting with a rotator cuff tear that is reparable surgically (a reparable tear is defined as tear of the RC where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus under minimal tension)\n* Ability to undergo surgery to repair rotator cuff tear\n* Willingness to commit to study procedures including study intervention and a 12-month follow-up\n* Fluency in speaking, reading, comprehending English\n* 1-2 tendon full thickness reparable RC tear (full thickness tear is defined as a tear that involves the majority of supraspinatus and less than half of the infraspinatus under minimal tension, with no subscapularis involvement beyond the upper border)\n\nExclusion Criteria:\n\n* Previous shoulder surgery (excluding acromioplasty or diagnostic arthroscopy)\n* Inability to receive an MRI\n* Current (within the past 6 months) tobacco user\n* Unwilling to remain tobacco free for the duration of the study\n* Current lower limb injuries requiring walking assist devices such as crutches and walkers\n* Diagnosed with systemic arthritis\n* Significant neck pathology\n* Active joint or systemic infection\n* Currently enrolled, or plans to enroll, in another clinical trial during this study (that would affect the patient's safety or results of this trial)\n* Significant muscle paralysis of the shoulder girdle\n* Currently pregnant or plans to become pregnant during this study\n* Inability of the surgeon to repair the tear with remaining defect no greater than 10 mm in diameter\n* Inability of the surgeon to repair the tear with less than 1cm of medialization\n* Evidence of other significant shoulder pathology including Type II-IV SLAP lesion, Bankart lesion, Hill Sachs lesion, Grade III osteoarthritis.\n* Has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction\n* Major medical illness that would preclude undergoing surgery\n* Major psychiatric illness or developmental handicap\n* Goutallier III classification and above",{"count":19,"type":20},[23],[26,27,28],"2024-06-05",{"date":238,"type":33},"2024-06-07",{"date":240,"type":20},"2024-07",{"date":242,"type":20},"2025-12",{"name":39,"class":40},""]