Osteoarthritis of the CMC-1 Joint Clinical Trial
This study is to evaluate the performance of the Articulinx ICMC (InterCarpoMetacarpalCushion) in the carpometacarpal joint (CMC joint) and to describe the clinical results in patients who have been treated with this device. Expected results include the relief of symptoms and improvement of function in patients with symptomatic osteoarthritis (OA) of the CMC-1 joint. Evaluation of device performance will be achieved through measurements of pain, pain medication use, and joint function in up to 40 subjects. Each subject will be compared to their pre-surgery status for each endpoint.
The Articulinx ICMC is intended to be implanted into the basilar, or first carpometacarpal
(CMC) joint, as an interpositional spacer between the first metacarpal and trapezium bones.
The device is intended to be used in the treatment of thumb disabilities resulting from
osteoarthritis of the CMC‐1 joint.
The primary objective is to document the performance of the Articulinx ICMC by evaluating
pain relief in the CMC joint following device implantation. CMC-1 joint function will be
assessed by measurement of lateral key and tripod pinch strength, grip strength, and range
of motion. Patient reported physical functioning and symptoms will be measured by DASH
scores. Trapezial height will be measured on standard PA xrays of the CMC joint. Incidence
of unanticipated device and procedure related adverse events will be documented
intraoperatively through one year follow-up.
Primary and secondary outcomes will be evaluated through one year and subjects will continue
to be followed for two years for evaluation of longer term performance.
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Observational Model: Case-Only, Time Perspective: Prospective