[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627738":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":35,"collaborators":37,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":19,"eligibilityCriteria":46,"healthyVolunteers":43,"sex":47,"minAge":48,"maxAge":19,"enrollmentInfo":49,"targetDuration":19,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":19,"overallStatus":58,"whyStopped":19,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":19},{"fullName":5,"class":6},"RevBio","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Augmented with Tetranite Bone Adhesive","EXPERIMENTAL","Participants will receive typical standard of care treatment for AO\u002FOTA type 2R3C distal radius fracture augmented with tetranite bone adhesive.",[13],"Combination Product: Augmented with Tetranite Bone Adhesive",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"COMBINATION_PRODUCT","Participants will receive typical standard of care treatment for AO\u002FOTA type 2R3C distal radius fractures augmented with tetranite bone adhesive.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Steven Glickel, MD","NYU Langone","STUDY_CHAIR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Brittany McDonough","CONTACT","781-520-9611","bmcdonough@revbio.com",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Gracie Cleaver","862-202-3109","gcleaver@revbio.com",{"type":36,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[38],{"name":39,"class":40},"National Institute on Aging (NIA)","NIH","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":50,"type":51},20,"ESTIMATED","INTERVENTIONAL",[54],"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)",[57],"AO\u002FOTA Type 2R3C Distal Radius Fracture","NOT_YET_RECRUITING","2026-03-02",{"date":61,"type":62},"2026-03-05","ACTUAL",{"date":64,"type":51},"2026-04-15",{"date":66,"type":51},"2027-06-15",{"name":5,"class":6}]