The WristArt implant will be implanted for the first time in humans' wrists
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
implantation of the WristArt implant
Kaplan Medical Center
Rehovot, Israel
RECRUITINGNumber of Device Related Serious Adverse events at 6 months post operation
Implantation Safety profile at 6 months post operation
Time frame: 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
Time frame: 48 hours post-surgery
Number of Device Related Serious Adverse events at 24 months post operation
Implantation Safety profile at 24 months post operation
Time frame: 24 months following implantation
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)
Time frame: 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)
Time frame: 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
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Average levels of change in Range of motion as measured by a goniometer
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
levels of change in Range of motion
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years
Implant loosening rate per radiological measurements
Implant loosening rate per radiological measurements
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 1 month, 3 months, 6 months, 1 year, 2 years