WristArt Total Wrist Arthroplasty Implant First In Human Study

Launched by FIBIOSEQ MEDICAL · Dec 25, 2023

Keywords

ClinConnect Summary

The WristArt Total Wrist Arthroplasty Implant First In Human Study is testing a new implant designed to help people with wrist osteoarthritis and other wrist problems. This trial is seeking participants aged 65 to 74 who have conditions like osteoarthritis, rheumatoid arthritis, or previous wrist injuries that can no longer be repaired. To qualify, potential participants need to have significant pain and disability in their wrist, as shown by their scores on specific tests.

If you join this study, you'll be among the first to receive this new implant. The trial aims to see how well it works and what results it can bring for people suffering from wrist issues. It's important to note that this study is only open to older adults, and there are specific health criteria that must be met to ensure safety. Participants will be monitored closely during the study to track their progress and any effects of the implant. Your involvement could help improve treatment options for others with similar wrist conditions in the future.

Gender

ALL

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.)