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WristArt Total Wrist Arthroplasty Implant First In Human Study

Israel5 participantsStarted 2024-01-02

Plain-language summary

The WristArt implant will be implanted for the first time in humans' wrists

Who can participate

Age range

18 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

. Subjects suffering from one the following conditions:
. Osteoarthritis (OA) of the wrist joint due to various causes (age, trauma, Avascular Necrosis)
. Rheumatoid arthritis of the wrist joint or other rheumatological diseases which destroy the wrist joint
. Unrepairable previous intraarticular fractures of the distal radius, scaphoid or lunate bones of the wrist joint (i.e., historical fractures that were failed to fuse surgically)
. Symptomatic congenital abnormalities around wrist joint such as carpal bones coalition, mild forms of Madelung's deformities etc.
. Patients who underwent failed proximal row carpectomy, or failed partial carpal bones fusion
. Patients who's their wrist x-ray shows no damage to the carpal bones that are not fused as part of the surgery
. Patient Rated Wrist Evaluation Score (PRWE) at baseline is above 70 points out of 100

Exclusion criteria

. Patients younger than 18 years old
. Patients for whom bone growth did not complete yet

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

Number of Device Related Serious Adverse events at 6 months post operation

Timeframe: 6 months post operation

Number of cases with Fully and successfully implanted device at the end of surgery per surgeon's reporting and radiological imaging

Timeframe: 48 hours post-surgery

Trial details

NCT IDNCT06196528

SponsorFibioseq Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-30

Contact for this trial

Amir Oron, MD

972-8-9441340 amiroronmd@gmail.com

View on ClinicalTrials.gov More Wrist Osteoarthritis trials