Clinical Evaluation of the Articulinx InterCarpoMetacarpal Cushion (ICMC) for Osteoarthritis of the First Metacarpal Joint
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|ClinicalTrials.gov Identifier: NCT01973803|
Recruitment Status : Unknown
Verified October 2013 by Articulinx.
Recruitment status was: Enrolling by invitation
First Posted : November 1, 2013
Last Update Posted : November 1, 2013
|Condition or disease|
|Osteoarthritis of the CMC-1 Joint|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2016|
- Average CMC joint pain score [ Time Frame: One year ]The post-operative VAS pain score will be compared to pre-operative baseline VAS pain score at one year.
- Change in joint function [ Time Frame: One year ]Change in joint function post‐procedure compared to pre‐operative baseline. Measurements of contralateral hand function will be taken at baseline and at subsequent follow‐up visits through one year.
- Change in DASH scores [ Time Frame: One year ]Change in DASH scores post‐procedure as compared to pre‐operative baseline
- Maintenance of trapezial joint space height [ Time Frame: One year ]Maintenance of trapezial joint space height compared to pre‐operative baseline.
- Incidence of unanticipated device and procedure related adverse events [ Time Frame: One year ]Incidence of unanticipated device and procedure related adverse events intraoperatively and through one year follow‐up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973803
|Koblenz, Germany, 56068|
|Berufsgenossenschaftliche (B-G) Unfallklinik Tübingen|
|Tubingen, Germany, 72076|
|University of Wurzburg, Klinik und Poliklinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie|
|Wurzburg, Germany, 97080|
|Principal Investigator:||Prof. Rainer Meffert, MD||University of Wurzburg, Klinik und Poliklinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie|