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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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.)

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

NCT IDNCT06196528

SponsorFibioseq Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-30

Amir Oron, MD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.)