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

NCT07452536 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: DVAL24003SB1AG085803
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

AO/OTA Type 2R3C Distal Radius Fracture

Outcome Measures

Primary Outcomes (3)

• Safety based on the rate of serious device related adverse events

  Safety based on the rate of serious device related adverse events

  For 52 weeks following surgery

• Efficacy based on the fracture union assessment at the 26-week follow-up

  Fracture union assessment at the 26-week follow-up

  26 weeks

• Efficacy based on the DASH assessment at the 26-week timepoint

  DASH assessment at the 26-week timepoint

  26 weeks

Secondary Outcomes (7)

• Grip strength compared to baseline (contralateral limb)

  6 weeks post surgery to 52 weeks post surgery

• Range of motion compared to baseline (contralateral limb)

  2 weeks post surgery to 52 weeks post surgery

• Patient reported outcome measure: SF-36

  2 weeks post surgery to 52 weeks post surgery

• Patient reported outcome measure: DASH

  2 weeks post surgery to 52 weeks post surgery

• Patient reported outcome measure: VAS Pain Score

  2 weeks post surgery to 52 weeks post surgery

Study Arms (1)

Augmented with Tetranite Bone Adhesive

EXPERIMENTAL

Participants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fracture augmented with tetranite bone adhesive.

Combination Product: Augmented with Tetranite Bone Adhesive

Interventions

Augmented with Tetranite Bone Adhesive COMBINATION_PRODUCT

Participants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fractures augmented with tetranite bone adhesive.

Augmented with Tetranite Bone Adhesive

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female, greater than 21 years of age
• Subject living independently and ambulatory at the time of injury.
• Subject, and/or subject's representatives are able and willing to provide informed consent and HIPAA authorization.
• Subject able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.
• No sign of active infection at the planned operative site.
• 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.

You may not qualify if:

• Significant ligamentous disruption requiring independent repair
• Pathological fracture related to an underlying malignancy
• Open fractures
• A previous fracture in the injured bone within the last 12 months
• Presence of other orthopaedic implant in the injured bone
• Patients with presumptive diagnosis of named nerve or blood vessel injury
• Current infection (either superficial or deep) at the planned operative site
• Sepsis within one week from the planned index procedure
• History of radiotherapy to the area
• Active chemotherapy treatment
• Patients receiving treatment with biologics for systemic inflammatory disease (e.g., Enbrel)
• Physically or mentally compromised and unable to provide consent or perform functional examinations
• Subject has a condition with anticipated survival shorter than 12 months

Sponsors & Collaborators

• RevBio: lead
• National Institute on Aging (NIA): collaborator

Study Officials

• Steven Glickel, MD

  NYU Langone

  STUDY CHAIR

Central Study Contacts

Brittany McDonough

CONTACT

781-520-9611; bmcdonough@revbio.com

Gracie Cleaver

CONTACT

862-202-3109; gcleaver@revbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 5, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share