WristArt Total Wrist Arthroplasty Implant First In Human Study
NCT ID: NCT06196528
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5 participants
INTERVENTIONAL
2024-01-02
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WristArt implantation
WristArt implant
implantation of the WristArt implant
Interventions
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WristArt implant
implantation of the WristArt implant
Eligibility Criteria
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Inclusion Criteria
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
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.)
18 Years
ALL
No
Sponsors
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Fibioseq Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Amir Oron
Role: PRINCIPAL_INVESTIGATOR
Kaplan Medical Center
Locations
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Kaplan Medical Center
Rehovot, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLN-0001
Identifier Type: -
Identifier Source: org_study_id
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