Prospective, multicentric non-comparative confirmatory study to evaluate the safety and performance of the InDx CMC implant for the treatment of CMC joint arthritis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
The InDx CMC Implant is a hemiarthroplasty device for the CMC joint which consists of a unified assembly of three components: metacarpal stem, polyethylene liner, and articulating head. Because the device functions as a hemiarthroplasty, it does not link or constrain the CMC joint
Az Sint-Jan Brugge AV
Bruges, Belgium
RECRUITINGDevice Safety
Determine the incidence of device failure, encompassing mechanical malfunction, structural compromise, loss of functionality due to device failure, or any deviation from the device's intended medical purpose. This will involve monitoring for adverse events requiring total revision surgery, or premature termination of device usage due to device failure.
Time frame: 6 Months
Performance
Measure the improvement in hand and wrist functionality using the Disabilities of the Arm, Shoulder, and Hand (DASH) score.
Time frame: 12 Months
Performance
Measure the improvement in hand and wrist functionality using the Patient-Rated Wrist/Hand Evaluation (PRWHE)
Time frame: 12 Months
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