About this trial
A prospective, multi-center (up to 4 sites), single-arm, study of 20 subjects. Patient enrollment will consist of subjects with an AO/OTA type 2R3C distal radius fracture. Enrollment will be prospectively stratified based on patient age (Stratum A: \<65 and Stratum B: ≥65 years)
Eligibility criteria
Qualifiers
Unilateral, unstable and/or displaced distal radius AO/OTA type 2R3C fracture.
Standard treatment would consist of open reduction internal fixation (ORIF) with plate(s) and screws using a volar approach
Surgical visit occurs within 2 weeks of injury.
No radiographic evidence of fracture healing prior to surgical treatment.
Disqualifiers
Significant ligamentous disruption requiring independent repair
Other fractures of the carpal bones or injured limb (Note: an associated ulnar styloid fracture is not exclusionary)
Pathological fracture related to an underlying malignancy
Open fractures
Trial design
Treatments tested in this trial
- Augmented with Tetranite Bone Adhesive
Treatment groups
Locations
Sponsors and collaborators
RevBio
Lead sponsor
National Institute on Aging (NIA)
Collaborator