First human use of the WristArt total wrist implant

WristArt Total Wrist Arthroplasty Implant First In Human Study

This study is testing a new wrist implant to see if it can help people with wrist arthritis feel less pain and improve how well they can use their wrist.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fibioseq Medical (Industry-sponsored)
• Locations: 1 site (Reẖovot)
• Trial ID: NCT06196528 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the WristArt total wrist arthroplasty implant in patients suffering from wrist osteoarthritis and other related conditions. The implant will be introduced for the first time in humans, focusing on individuals with significant wrist pain and functional impairment. Participants will undergo the surgical procedure to receive the implant, and their outcomes will be monitored to assess improvements in pain and wrist function.

Who should consider this trial

Good fit: Ideal candidates include individuals with wrist osteoarthritis, rheumatoid arthritis, or other conditions leading to severe wrist joint damage.

Not a fit: Patients with intact carpal bones or those who do not meet the specified pain and functional impairment criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this implant could significantly improve wrist function and reduce pain for patients with severe wrist conditions.

How similar studies have performed: While this is the first human trial for the WristArt implant, similar arthroplasty approaches have shown promise in other joints, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Subjects suffering from one the following conditions:

   1. Osteoarthritis (OA) of the wrist joint due to various causes (age, trauma, Avascular Necrosis)
   2. Rheumatoid arthritis of the wrist joint or other rheumatological diseases which destroy the wrist joint
   3. 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)
   4. Symptomatic congenital abnormalities around wrist joint such as carpal bones coalition, mild forms of Madelung's deformities etc.
   5. Patients who underwent failed proximal row carpectomy, or failed partial carpal bones fusion
2. Patients who's their wrist x-ray shows no damage to the carpal bones that are not fused as part of the surgery
3. Patient Rated Wrist Evaluation Score (PRWE) at baseline is above 70 points out of 100
4. Visual Analog Pain Score (VAS) at baseline is above 70 points out of 100

Exclusion Criteria:

1. Patients younger than 18 years old
2. Patients for whom bone growth did not complete yet
3. Paralytic hand patients
4. Patients with sensitivity to Titanium (ADD/CHANGE MATERIALS AS NEEDED)
5. Cerebral palsy patients with wrist joint contracture and loss of sensation in the hand
6. Low quality of capitate bone and/or excessively short capitate bone (≥50% destruction) due to various causes (AVN, comminuted fracture, lytic lesions, congenital etc.)

Where this trial is running

Reẖovot

• Kaplan Medical Center — Reẖovot, Israel (Recruiting)

Study contacts

• Principal investigator: Amir Oron — Kaplan Medical Center
• Study coordinator: Amir Oron, MD

Conditions Wrist Osteoarthritis