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

March 2, 2026 updated by: RevBio
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety based on the rate of serious device related adverse events
Time Frame: For 52 weeks following surgery
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
Time Frame: 26 weeks
Fracture union assessment at the 26-week follow-up
26 weeks
Efficacy based on the DASH assessment at the 26-week timepoint
Time Frame: 26 weeks
DASH assessment at the 26-week timepoint
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Grip strength compared to baseline (contralateral limb)
Time Frame: 6 weeks post surgery to 52 weeks post surgery
Grip strength compared to baseline (contralateral limb)
6 weeks post surgery to 52 weeks post surgery
Range of motion compared to baseline (contralateral limb)
Time Frame: 2 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
Time Frame: 2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measures: SF-36
2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measure: DASH
Time Frame: 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
Time Frame: 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
Maintenance of reduction compared to baseline (surgery)
Time Frame: Surgery
Maintenance of reduction compared to baseline (surgery)
Surgery
Fracture union assessment at the 6-,12-week follow-ups
Time Frame: 6-,12-week follow-ups
Fracture union assessment at the 6-,12-week follow-ups
6-,12-week follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RevBio

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Steven Glickel, MD, NYU Langone

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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