A first-in-human proof-of-concept study with NVDX3, an osteogenic implant of human allogenic origin, in the treatment of distal radius fractures in adults.
This study is looking at a new treatment called NVDX3 for adults who have broken their wrist, specifically the bone near the hand (distal radius fracture). NVDX3 is a special type of implant that comes from human bone and is designed to help new bone grow. This is one of the very first times this treatment is being used in people, so the main aims are to check if it's safe and to see how well it works. It's a combined Phase 1 and Phase 2 study, which means researchers will carefully monitor participants to understand the new treatment better.
At a glance
What is this study about?
This study is testing a new way to help fix broken wrists, specifically when the break is in the bone closest to your hand, called a distal radius fracture. When you break a bone, sometimes it needs a bit of extra help to heal properly, especially if the break is severe or complex. One way doctors can help is by performing a bone graft, which means adding extra bone material to encourage the healing process.
The new treatment being tested in this study is called NVDX3. It's an "osteogenic implant of human allogenic origin." In simpler words, this means it's a special material made from human bone that is designed to help your own bone cells grow and repair the break. The 'allogenic' part means it comes from a donor, not from your own body. The study's main goal is to see if this new material is safe to use in people and if it actually helps broken wrists heal better.
This is a very early stage study, often called a 'first-in-human' study (Phase 1 and Phase 2 combined). This means it's one of the first times this specific bone graft material is being used in people. Researchers will be carefully checking for any side effects and watching closely to see how well patients recover. The information they gather will help them decide if this treatment has the potential to become a standard option for broken wrists in the future.
Key takeaways
- This study is for adults with a broken wrist bone near the hand.
- It's testing a new bone graft material called NVDX3.
- This is a very early stage study to check safety and effectiveness.
- Participation involves receiving the new treatment and follow-up visits.
- All decisions to join are voluntary, with full right to withdraw.
- Both potential benefits and risks exist with any new treatment.
Who may be eligible?
This study is looking for adult volunteers who have broken their wrist (a distal radius fracture). To be considered, you must be at least 18 years old – there is no upper age limit, so people of any adult age can take part.
Both men and women are welcome to participate in this study. The medical team will check other health details to make sure the study is a safe and suitable option for you. This often includes reviewing your medical history, any other health conditions you might have, and medications you are currently taking.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you recently broken your wrist (distal radius fracture)?
- Are you comfortable with receiving an experimental treatment?
- Are you able to attend regular follow-up appointments?
What does participation involve?
The details of what participating would involve are not fully provided in this summary. However, in studies like this, potential participants typically have an initial screening visit to check if they are suitable. If eligible, you would likely undergo the surgical procedure to fix your broken wrist, where the NVDX3 implant would be used. After the procedure, you would have regular follow-up appointments with the study team. These visits would likely involve check-ups, X-rays to monitor bone healing, and discussions about how you are feeling and any effects you might be experiencing. The total duration of your participation, including follow-up, would be made clear to you by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is a distal radius fracture?
It's a common type of broken wrist, specifically a break in the bone closest to your hand (the radius bone).
What is NVDX3?
It's a new type of implant, made from human bone, designed to help your broken wrist bone heal and grow back stronger.
Is this treatment proven to work?
No, not yet. This is an early stage study (Phase 1 and 2), meaning it's being tested for the first time in people to see if it's safe and if it helps.
Will I get paid to participate?
The information provided does not state whether participants will be paid. This is a good question to ask the research team.
What if I change my mind after joining?
You are free to leave the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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