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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: AO/OTA Type 2R3C Distal Radius Fracture
• Intervention / Treatment: Combination product: Augmented with Tetranite Bone Adhesive

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gracie Cleaver; Phone Number: 862-202-3109; Email: gcleaver@revbio.com
• Study Contact Backup: Name: Brittany McDonough; Phone Number: 781-520-9611; Email: bmcdonough@revbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Intra-Operative Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented with Tetranite Bone Adhesive; 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; Participants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fractures augmented with tetranite bone adhesive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip strength compared to baseline (contralateral limb)	Grip strength compared to baseline (contralateral limb)	6 weeks post surgery to 52 weeks post surgery
Range of motion compared to baseline (contralateral limb)	Range of motion compared to baseline (contralateral limb)	2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measure: SF-36	Patient reported outcome measures: SF-36	2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measure: DASH	Patient reported outcome measure: DASH	2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measure: VAS Pain Score	Patient reported outcome measure: VAS Pain Score	2 weeks post surgery to 52 weeks post surgery
Maintenance of reduction compared to baseline (surgery)	Maintenance of reduction compared to baseline (surgery)	Surgery
Fracture union assessment at the 6-,12-week follow-ups	Fracture union assessment at the 6-,12-week follow-ups	6-,12-week follow-ups

Collaborators and Investigators

• Sponsor: RevBio
• Collaborators: National Institute on Aging (NIA)
• Investigators: Study Chair: Steven Glickel, MD, NYU Langone

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: DVAL24003; SB1AG085803 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes