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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RevBio · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

The proposed study design is prospective, multi-center, single-arm, and non-randomized. RevBio is working to establish up to four (4) clinical sites. RevBio will perform site initiation visits to provide training to the investigator and its staff. Training will include information about study-specific procedures, a detailed review of the study protocol, instruction in completion of the electronic case report forms (eCRFs), informing the site about device instructions for use, and discussion of the regulatory requirements of the investigator. Patients will be recruited from the general patient population based on inclusion/exclusion criteria. Once they sign the informed consent form and complete the screening process they will be enrolled in the study and scheduled for surgery. All data will be reported to the FDA to evidence safety and efficacy and substantiate advancing to future stages in a larger expanded study.

Conditions

• AO/OTA Type 2R3C Distal Radius Fracture

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Augmented with Tetranite Bone Adhesive	Participants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fractures augmented with tetranite bone adhesive.

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-12-15
• Completion: 2027-06-15
• First posted: 2026-03-05
• Last updated: 2026-03-05

Regulatory

• FDA-regulated device study