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 20 subjects. Each subject will be compared to their pre-surgery status for each endpoint.
The Articulinx ICMC is a minimally invasive orthopedic device 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 Articulinx ICMC is a molded polymer disc with an encapsulated radiopaque marker. The Articulinx ICMC is designed to be an inter-positional spacer for the treatment of symptoms of early-stage osteoarthritis of the first CMC joint. When properly positioned in the joint, the ICMC can preserve or restore normal space between the trapezium and thumb metacarpal bones in the first CMC joint. The restoration of natural spacing and biomechanics within the joint is expected to reduce pain and restore strength and function. The ICMC is designed to be implanted earlier in the OA disease process than other basilar joint implants. The ICMC allows a more active lifestyle and may reduce or eliminate the need for long-term use of prescribed arthritis medications. Because the ICMC procedure does not remove supportive bone or tissue, the procedure is reversible and treatment options for later stage disease progression remain available to patients. The ICMC was first placed on the EU (European Union) market by the Sponsor in April, 2011 following approval to carry the CE (European Community) Mark based upon successful pre-clinical and clinical testing. In other clinical studies, one single site study and one multicenter site study, both conducted in accordance with ISO 14155 (International Standards Organization), the 1-year enrollment is completed and 2-year follow-up is ongoing. The primary objective of this study is to document the safety of the Articulinx ICMC by evaluating Incidence of unanticipated device and procedure related adverse events intra-operatively, and through one year follow-up. The secondary objectives of this study are to describe clinical and radiographic outcomes in patients who are treated with the device. This is a single site study in The Netherlands. Study enrollment will begin following required regulatory submissions/Ethics Committee approval and after site study personnel training is completed. The study will be conducted in conformance with ISO 14155 and will evaluate the performance of the Articulinx ICMC for the relief of the symptoms of osteoarthritis in the CMC-1 joint. Primary and secondary study endpoints will be evaluated through one year and patients will continue to be followed for two years for evaluation of longer-term performance.
Study Type
OBSERVATIONAL
Enrollment
20
Vrij University Medical Center (VUmc)
Amsterdam, Netherlands
The primary endpoint of this study is the Incidence of unanticipated device and procedure related adverse events.
Reported incidence of unanticipated device and procedure related Adverse Events will be documented at all scheduled visits and within 24 hours of knowledge of an event.
Time frame: Intra-operatively and through one year follow-up.
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Changes in CMC-1 joint function post-procedure compared to preoperative baseline
Time frame: Post operative follow-up at 3mo, 6mo, and 12mo
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Changes in average CMC-1 joint pain score at the one-year postoperative follow-up compared to preoperative baseline
Time frame: Post operative follow-up at 3mo, 6mo, and 12mo
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Change in DASH scores post-procedure as compared to preoperative baseline
Time frame: Post operative follow-up at 3mo, 6mo, and 12mo.
Secondary outcome measures describe clinical and radiographic outcomes in patients treated with the device.
Maintenance of trapezial joint space height compared to pre-operative baseline
Time frame: Postoperative follow-up at 3mo, 6mo, and 12mo
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