A Pilot Clinical Study to Evidence Safety and Efficacy of Fracture Fixation of the Distal Radius … (NCT07452536) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
20 participantsStarted 2026-04-15
Plain-language 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)
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety based on the rate of serious device related adverse events
Timeframe: For 52 weeks following surgery
2
Efficacy based on the fracture union assessment at the 26-week follow-up
Timeframe: 26 weeks
3
Efficacy based on the DASH assessment at the 26-week timepoint