AO/OTA Type 2R3C Distal Radius FractureNCT07452536
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 study testing Augmented with Tetranite Bone Adhesive in people with AO/OTA Type 2R3C Distal Radius Fracture, run by RevBio.
Trial 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) Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- AO/OTA Type 2R3C Distal Radius Fracture
- What is being tested?
- Augmented with Tetranite Bone Adhesive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
Read the 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
- Being tested
- Augmented with Tetranite Bone Adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented with Tetranite Bone AdhesiveCombination product
Participants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fractures augmented with tetranite bone adhesive.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Augmented with Tetranite Bone Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety based on the rate of serious device related adverse events
Safety based on the rate of serious device related adverse events
Measured: 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
Measured: 26 weeks
Efficacy based on the DASH assessment at the 26-week timepoint
DASH assessment at the 26-week timepoint
Measured: 26 weeks
Secondary outcomes (7)
Grip strength compared to baseline (contralateral limb)
Grip strength compared to baseline (contralateral limb)
Measured: 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)
Measured: 2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measure: SF-36
Patient reported outcome measures: SF-36
Measured: 2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measure: DASH
Patient reported outcome measure: DASH
Measured: 2 weeks post surgery to 52 weeks post surgery
Patient reported outcome measure: VAS Pain Score
Patient reported outcome measure: VAS Pain Score
Measured: 2 weeks post surgery to 52 weeks post surgery
Maintenance of reduction compared to baseline (surgery)
Maintenance of reduction compared to baseline (surgery)
Measured: Surgery
Fracture union assessment at the 6-,12-week follow-ups
Fracture union assessment at the 6-,12-week follow-ups
Measured: 6-,12-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AO/OTA Type 2R3C Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RevBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Steven Glickel, MD, Study chair, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452536
- Sponsor's protocol ID
- DVAL24003
- Other IDs
- SB1AG085803
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07452536
- Acronym / sponsor ID
- DVAL24003
- Conditions
- AO/OTA Type 2R3C Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RevBioIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented with Tetranite Bone Adhesive | Experimental | Combination Product: Augmented with Tetranite Bone AdhesiveParticipants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fracture augmented with tetranite bone adhesive. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented with Tetranite Bone AdhesiveParticipants will receive typical standard of care treatment for AO/OTA type 2R3C distal radius fractures augmented with tetranite bone adhesive. | Combination product | Augmented with Tetranite Bone Adhesive |
Primary outcome
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
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
Efficacy based on the DASH assessment at the 26-week timepoint
Time frame: 26 weeks
DASH assessment at the 26-week timepoint
7 secondary outcomes
Grip strength compared to baseline (contralateral limb)
Time frame: 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
Patient reported outcome measure: SF-36
Time frame: 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: VAS Pain Score
Time frame: 2 weeks post surgery to 52 weeks post surgery
Maintenance of reduction compared to baseline (surgery)
Time frame: Surgery
Fracture union assessment at the 6-,12-week follow-ups
Time frame: 6-,12-week follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Glickel, MD study chair
NYU Langone
Questions about this trial
What is this clinical trial studying?
A study testing Augmented with Tetranite Bone Adhesive in people with AO/OTA Type 2R3C Distal Radius Fracture, run by RevBio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany McDonough (781-520-9611, bmcdonough@revbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety based on the rate of serious device related adverse events (time frame: For 52 weeks following surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.