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)
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.
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
Single group
Augmented with Tetranite Bone Adhesive
Combination productParticipants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fractures augmented with tetranite bone adhesive.
Safety based on the rate of serious device related adverse events
Safety based on the rate of serious device related adverse events
Efficacy based on the fracture union assessment at the 26-week follow-up
Fracture union assessment at the 26-week follow-up
Efficacy based on the DASH assessment at the 26-week timepoint
DASH assessment at the 26-week timepoint
Grip strength compared to baseline (contralateral limb)
Grip strength compared to baseline (contralateral limb)
Range of motion compared to baseline (contralateral limb)
Range of motion compared to baseline (contralateral limb)
Patient reported outcome measure: SF-36
Patient reported outcome measures: SF-36
Patient reported outcome measure: DASH
Patient reported outcome measure: DASH
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RevBio
Lead sponsor
National Institute on Aging (NIA)
Collaborator
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