Donated bone implant shows promise for tough wrist breaks
NCT ID NCT05987033
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tested a new implant called NVDX3, made from donated human bone cells, in 11 adults with severe wrist fractures. The implant was placed during a single surgery to help the bone heal. The main goal was to check safety, and researchers also looked at how well the bone healed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NVDX3 (an implant made from donated human bone cells)
- What this could lead to
- If it works, this could lead to a new way to help heal complex wrist fractures without needing a second surgery to take bone from elsewhere in the body.
- What could go wrong
- This is a very early, small study with only 11 people, so results may not apply to everyone. The main goal is safety, not yet proof that it works better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
11 people
The number who actually took part.
- Started
-
Aug 2023
- Finished
-
Dec 2024
- Lead sponsor
-
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
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
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: 1. Male or female patients within the age range of ≥18 years to ≤80 years. 2. Patient diagnosed with DRF with confirmed: 1. Classification AO/ATO: C2 and C3 - Intra-articular \& multifragmentation. 2. Estimated volume of the targeted bone void should not exceed 5cc. 3. Availability of diagnostic AP and LAT X-ray or CT scan. 3. Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis. 4. Patient fulfills criteria for undergoing a surgical intervention. 5. Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent. Exclusion Criteria: 1. Open DRF or closed DRF with increased infection risk. 2. Injury to the median nerve. 3. Previous fracture of the target distal radius. 4. Documented disease limiting mobility and functional assessments (eg. Grip strength test). 5. Dependency on crutches or any comparable walking aids. 6. Patient is overweight, has a BMI ≥35. 7. Presence of clinically significant infection at the target implant site or systemic infection. 8. History of allergic reaction or any anticipated hypersensitivity to any of the anticipated: 1. Osteosynthesis materials (PEEK plate and screws). 2. Anesthetic agents. 3. Components of the NVDX3 implant. 9. Presence of any auto-immune disease, with exception of well controlled diabetes type-1 or II, or auto-immune thyroid disorders. 10. Positive serology for human immunodeficiency virus (HIV), HBcAb and/or HBsAg. 11. Presence of an active tumor. 12. Documented metabolic bone disease or any disorder, such as but not limited to high-risk osteoporosis, that could interfere with the bone healing and bone metabolism. 13. Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulants, immunosuppressants or immunotherapy. 14. Excessive smoking, history of chronic alcohol or drug abuse within the 12 months prior to screening. 15. Any history of experimental therapy with another investigational drug within 60 days prior to screening. 16. Pregnant women or women of childbearing potential (WOCBP) not agreeing to use an effective method of birth control3 during the course of the study. Note: WOCBP including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test before entering in the study. 17. Any other psychosocial, mental and physical condition which, in the opinion of the investigator, could interfere with the trial conduct, the patient's compliance or influence interpretation of the results. 18. Patient with historically elevated radiation exposure levels that could in the opinion of the investigator have introduced unacceptable radiation risks for the patient, when being accumulated with the radiological examinations planned in this study.
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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.
Contacts and locations
Locations
-
Centre Hospitalier de Luxembourg
Luxembourg, 1210, Luxembourg
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Arm nerve block tested to cut surgery after wrist fracture
- Can a simple video boost wrist surgery recovery?
- X-Ray clues could spare some patients from wrist surgery
- Could a gentle electric pulse rebuild a broken wrist faster?
- Wrist fracture study tests simpler treatment against standard care
- ER wrist reset may be unnecessary for some breaks