Wrist Osteoarthritis
Conditions
Brief summary
The WristArt implant will be implanted for the first time in humans' wrists
Interventions
DEVICEWristArt implant
implantation of the WristArt implant
Sponsors
Fibioseq Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Device Related Serious Adverse events at 6 months post operation | 6 months post operation | Implantation Safety profile at 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 | 48 hours post-surgery | Implantation Success profile at the end of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average levels of change in functionality according to Patient Reported Wrist Evaluation (PRWE) | 1 month, 3 months, 6 months, 1 year, 2 years | 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) |
| Average levels of change in Grip Strength as measured by dynamometer | 1 month, 3 months, 6 months, 1 year, 2 years | levels of change in Grip Strength as measured by a dynamometer |
| Average levels of change in Range of motion as measured by a goniometer | 1 month, 3 months, 6 months, 1 year, 2 years | levels of change in Range of motion |
| Number of Device Related Serious Adverse events at 24 months post operation | 24 months following implantation | Implantation Safety profile at 24 months post operation |
| Metal Ion Levels in blood at 1 year following surgery | 1 year | Metal Ion Levels in blood at 1 year following surgery |
| Average Surgical Satisfaction Questionnaire (SSQ-8) | 1 year | 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) |
| Levels of change in functionality according to quick DASH scores (0 - full function ; 100 - impaired functionality) | 1 month, 3 months, 6 months, 1 year, 2 years | Levels of change in functionality according to quick DASH scores |
| Implant loosening rate per radiological measurements | 1 month, 3 months, 6 months, 1 year, 2 years | Implant loosening rate per radiological measurements |
| Average Pain Reduction levels according to Visual Analog Pain Score (VAS) | 1 month, 3 months, 6 months, 1 year, 2 years | 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) |
Countries
Israel
Contacts
Primary ContactAmir Oron, MD
Backup ContactShiran Rogof
Outcome results
None listed