[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aoota-type-2r3c-distal-radius-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aoota-type-2r3c-distal-radius-fracture":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100627738","a-pilot-clinical-study-to-evidence-safety-and-efficacy-of-fracture-fixation-of-the-distal-radius-using-a-bioresorbable-bone-adhesive-to-augment-metal-hardware-100627738",false,"NCT07452536","A Pilot Clinical Study to Evidence Safety and Efficacy of Fracture Fixation of the Distal Radius Using a Bioresorbable Bone Adhesive to Augment Metal Hardware","Inclusion Criteria:\n\n* Unilateral, unstable and\u002For displaced distal radius AO\u002FOTA type 2R3C fracture.\n* Standard treatment would consist of open reduction internal fixation (ORIF) with plate(s) and screws using a volar approach\n* Surgical visit occurs within 2 weeks of injury.\n* No radiographic evidence of fracture healing prior to surgical treatment.\n* Male or female, greater than 21 years of age\n* Subject living independently and ambulatory at the time of injury.\n* Subject, and\u002For subject's representatives are able and willing to provide informed consent and HIPAA authorization.\n* Subject able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.\n\nIntra-Operative Inclusion Criteria:\n\n* No sign of active infection at the planned operative site.\n* Surgeons will decide whether the fracture site is a good candidate for TN-MFF use once the site is open and they can visualize the bone and surrounding soft tissue.\n\nExclusion Criteria:\n\n* Significant ligamentous disruption requiring independent repair\n* Other fractures of the carpal bones or injured limb (Note: an associated ulnar styloid fracture is not exclusionary)\n* Pathological fracture related to an underlying malignancy\n* Open fractures\n* A previous fracture in the injured bone within the last 12 months\n* Presence of other orthopaedic implant in the injured bone\n* Patients with presumptive diagnosis of named nerve or blood vessel injury\n* Current infection (either superficial or deep) at the planned operative site\n* Sepsis within one week from the planned index procedure\n* History of radiotherapy to the area\n* Active chemotherapy treatment\n* Patients receiving treatment with biologics for systemic inflammatory disease (e.g., Enbrel)\n* Physically or mentally compromised and unable to provide consent or perform functional examinations\n* Subject has a condition with anticipated survival shorter than 12 months","ALL","21 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"NA","A prospective, multi-center (up to 4 sites), single-arm, study of 20 subjects. Patient enrollment will consist of subjects with an AO\u002FOTA type 2R3C distal radius fracture. Enrollment will be prospectively stratified based on patient age (Stratum A: \\\u003C65 and Stratum B: ≥65 years)",[25],"AO\u002FOTA Type 2R3C Distal Radius Fracture","NOT_YET_RECRUITING","2026-03-02",{"date":29,"type":30},"2026-03-05","ACTUAL",{"date":32,"type":19},"2026-04-15",{"date":34,"type":19},"2027-06-15",{"name":36,"class":37},"RevBio","INDUSTRY"]