[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CONMED Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100515889","biobrace-implant-for-arthroscopic-repair-of-full-thickness-rotator-cuff-tears-100515889",false,"NCT05997381","BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears","REinForce: A Prospective, Single Blind, Multi-Center, Randomized, Controlled, Pivotal Study to Evaluate the Safety and Effectiveness of the BioBrace® Implant During Arthroscopic Repair of Full Thickness Rotator Cuff Tears","REinForce","Inclusion Criteria:\n\n1. Male or female 40 to 70 years old\n2. Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT):\n\n   1. Tear of the supraspinatus and\u002For infraspinatus tendons\n   2. Tear size ≥ 2 cm and \\\u003C 5 cm\n3. Chronic shoulder pain ≥ 3 months\n4. Failed non-operative treatment of the index shoulder to include one or all of the following:\n\n   1. Oral analgesics\n   2. Nonsteroidal anti-inflammatory medications (NSAIDs)\n   3. Corticosteroid injections\n   4. Activity modifications\n   5. Physical therapy or home-guided exercises\n5. Able to read and understand the study REB\u002FIRB approved Informed Consent Form (ICF)\n6. Willing to be available to attend each protocol-required follow-up examination\n\nIntraoperative Inclusion Criteria:\n\n1. Full thickness tear of the supraspinatus and\u002For infraspinatus tendons\n2. Tear size ≥ 2 cm and \\\u003C 5 cm\n3. Able to reapproximate the tendons to cover \\> 50% of the footprint on the greater tuberosity\n\nExclusion Criteria:\n\n1. Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy\n2. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score)\n3. Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator\n4. Oral steroid use or steroid injection within 6 weeks prior to surgery\n5. Active smoker\n6. History of insulin-dependent diabetes\n7. Documented evidence of a history (e.g., liver testing) of drug\u002Falcohol abuse within 12 months of enrollment\n8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)\n9. Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder\n10. History of claustrophobia that would prevent an MRI of the index shoulder\n11. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study\n12. Currently participating, or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator\n13. History of non-compliance with medical treatment or clinical trial participation\n14. The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up\n15. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator\n16. The subject is receiving prescription narcotic pain medication\n17. The subject currently has an acute infection in the area surrounding the surgical site\n18. Contralateral shoulder condition where rotator cuff repair is scheduled or to be scheduled over the course of this study\n19. The subject's condition represents a worker's compensation case\n\nIntraoperative Exclusion Criteria:\n\n1\\. Subject requires subscapularis repair other than a repair with a single anchor",true,"ALL","40 Years","70 Years",{"count":22,"type":23},268,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.",[29],"Rotator Cuff Tears",[31,32,33],"Rotator cuff tear","Full thickness tear","BioBrace","RECRUITING","2026-04-20",{"date":37,"type":38},"2026-04-23","ACTUAL",{"date":40,"type":38},"2024-01-05",{"date":42,"type":23},"2027-06",{"name":44,"class":45},"CONMED Corporation","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":18,"minAge":54,"maxAge":20,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100588990","biobrace-augmentation-in-anterior-cruciate-ligament-reconstruction-procedures-100588990","NCT06948591","BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures","Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures","Inclusion Criteria:\n\n1. Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®.\n2. Between 14 and 70 years old at the time of surgery.\n3. Can understand the content of the subject information \u002F Informed Consent Form (ICF) for the prospective portion of the study.\n4. Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.\n5. If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively:\n\n   1. International Knee Documentation Committee (IKDC)\n   2. Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)\n   3. Patient-Reported Outcomes Measurement Information System (PROMIS-10)\n   4. Tegner Activity Scale (TAS)\n   5. Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)\n6. Positive diagnostic imaging by MRI at baseline indicating an ACL tear\n\nExclusion Criteria:\n\n1. Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.\n2. Is currently participating in an investigational therapy (device and\u002For pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study.\n3. Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).\n4. Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.","14 Years",{"count":56,"type":23},500,"OBSERVATIONAL","This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.",[60],"ACL Tears",[62,33,63],"ACL reconstruction","augmentation","2026-04-13",{"date":66,"type":38},"2026-04-14",{"date":68,"type":38},"2025-04-08",{"date":70,"type":23},"2030-06",{"name":44,"class":45},""]