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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorRevBio

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

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

RevBio

Lead sponsor

National Institute on Aging (NIA)

Collaborator