Bone glue could make wrist surgery stronger
NCT ID NCT07452536
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special bone glue that dissolves over time, used alongside metal plates and screws to fix a broken wrist. About 20 adults with a specific type of wrist fracture will receive the glue during standard surgery. Researchers will check if the glue is safe and helps the bone heal better by 26 weeks after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.