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Clinical Evaluation of the Articulinx InterCarpoMetacarpal Cushion (ICMC) for Osteoarthritis of the First Metacarpal Joint

NCT01973803 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2013-11-01

No results posted yet for this study

Summary

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.

Conditions

  • Osteoarthritis of the CMC-1 Joint

Sponsors & Collaborators

  • Articulinx

    lead INDUSTRY

Principal Investigators

  • Prof. Rainer Meffert, MD · University of Wurzburg, Klinik und Poliklinik für Unfall-, Hand-, Plastische und Wiederherstellungschirurgie

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-12-31
Completion
2016-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01973803 on ClinicalTrials.gov