Status:
RECRUITING
WristArt Total Wrist Arthroplasty Implant First In Human Study
Lead Sponsor:
Fibioseq Medical
Conditions:
Wrist Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The WristArt implant will be implanted for the first time in humans' wrists
Eligibility Criteria
Inclusion
- 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
- Visual Analog Pain Score (VAS) at baseline is above 70 points out of 100
Exclusion
- Patients younger than 18 years old
- Patients for whom bone growth did not complete yet
- Paralytic hand patients
- Patients with sensitivity to Titanium (ADD/CHANGE MATERIALS AS NEEDED)
- Cerebral palsy patients with wrist joint contracture and loss of sensation in the hand
- Low quality of capitate bone and/or excessively short capitate bone (≥50% destruction) due to various causes (AVN, comminuted fracture, lytic lesions, congenital etc.)
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06196528
Start Date
January 2 2024
End Date
February 28 2026
Last Update
February 22 2024
Active Locations (1)
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1
Kaplan Medical Center
Rehovot, Israel