WristArt Total Wrist Arthroplasty Implant First In Human Study

Fibioseq Medical

Status: Enrolling

Conditions: Wrist Osteoarthritis

Treatments: Device: WristArt implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06196528

CLN-0001

Details and patient eligibility

About

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

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

WristArt implantation

Experimental group

Treatment:

Device: WristArt implant