Early Stage Osteoarthritis of the CMC-1 Joint Clinical Trial
Official title:
Clinical Evaluation of the Articulinx InterCarpoMetacarpal Cushion (ICMC) for Osteoarthritis of the First CarpoMetacarpal Joint: A New Study of the ICMC in a Clinical Setting
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.
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Observational Model: Cohort, Time Perspective: Prospective