Wrist Osteoarthritis Clinical Trial
Official title:
WristArt Total Wrist Arthroplasty Implant First In Human Study
The WristArt implant will be implanted for the first time in humans' wrists
Status | Recruiting |
Enrollment | 5 |
Est. completion date | February 28, 2026 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
Israel | Kaplan Medical Center | Re?ovot |
Lead Sponsor | Collaborator |
---|---|
Fibioseq Medical |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Device Related Serious Adverse events at 6 months post operation | Implantation Safety profile at 6 months post operation | 6 months post operation | |
Primary | Number of cases with Fully and successfully implanted device at the end of surgery per surgeon's reporting and radiological imaging | Implantation Success profile at the end of surgery | 48 hours post-surgery | |
Secondary | Number of Device Related Serious Adverse events at 24 months post operation | Implantation Safety profile at 24 months post operation | 24 months following implantation | |
Secondary | Average Pain Reduction levels according to Visual Analog Pain Score (VAS) | Pain is calculated using a visual analog scale ranges from 1-10 (taken from the pain subscale of the Patient Reported Wrist Evaluation PRWE scale) | 1 month, 3 months, 6 months, 1 year, 2 years | |
Secondary | Average levels of change in functionality according to Patient Reported Wrist Evaluation (PRWE) | The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. scores range from 0 (no disability) to 100 (worse functional score) | 1 month, 3 months, 6 months, 1 year, 2 years | |
Secondary | Average levels of change in Grip Strength as measured by dynamometer | levels of change in Grip Strength as measured by a dynamometer | 1 month, 3 months, 6 months, 1 year, 2 years | |
Secondary | Average levels of change in Range of motion as measured by a goniometer | levels of change in Range of motion | 1 month, 3 months, 6 months, 1 year, 2 years | |
Secondary | Implant loosening rate per radiological measurements | Implant loosening rate per radiological measurements | 1 month, 3 months, 6 months, 1 year, 2 years | |
Secondary | Metal Ion Levels in blood at 1 year following surgery | Metal Ion Levels in blood at 1 year following surgery | 1 year | |
Secondary | Average Surgical Satisfaction Questionnaire (SSQ-8) | SSQ8 is a 8-items instrument, with responses recorded on a 5-point Likert-type scale from 0 (worst) to 4 (best) and an overall score ranging from 0 (very unsatisfied) to 32 (very satisfied) | 1 year | |
Secondary | Levels of change in functionality according to quick DASH scores (0 - full function ; 100 - impaired functionality) | Levels of change in functionality according to quick DASH scores | 1 month, 3 months, 6 months, 1 year, 2 years |
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