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The WristArt implant will be implanted for the first time in humans' wrists
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WristArt implantation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WristArt implant | Device | implantation of the WristArt implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Device Related Serious Adverse events at 6 months post operation | Implantation Safety profile at 6 months post operation | 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 | Implantation Success profile at the end of surgery | 48 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Device Related Serious Adverse events at 24 months post operation | Implantation Safety profile at 24 months post operation | 24 months following implantation |
| Average Pain Reduction levels according to Visual Analog Pain Score (VAS) |
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Inclusion Criteria:
Subjects suffering from one the following conditions:
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
Visual Analog Pain Score (VAS) at baseline is above 70 points out of 100
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir Oron, MD | Contact | 972-8-9441340 | amiroronmd@gmail.com | |
| Shiran Rogof | Contact | +97289441340 | shiranro1@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Amir Oron | Kaplan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaplan Medical Center | Recruiting | Rehovot | Israel |
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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 |
| 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 |
| 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 |
| 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 |
| Implant loosening rate per radiological measurements | Implant loosening rate per radiological measurements | 1 month, 3 months, 6 months, 1 year, 2 years |
| Metal Ion Levels in blood at 1 year following surgery | Metal Ion Levels in blood at 1 year following surgery | 1 year |
| 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 |
| 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 |