Clinical evaluation of the Articulinx device for the carpometacarpal joint.

Completed

• Conditions: Rizarthrosis; thumb arthritis; 10023213

• Registration Number: NL-OMON38020
• Lead Sponsor: Articulinx Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Adults 35 -75 years old with osteoarthritis of the carpometacarpal (CMC-I) joint. VAS- painscore > 40 at baseline. Subluxation less than 1/3. Patients capable of providing informed consent.

Exclusion Criteria

Significant and affecting pathology of the radial side of the hand and wrist.
Significant osteophytes (> 2 mm) and free floating bodies in CMC-I joint
Rheumatoid and/or Metabolic disorders of the bone.
Prior surgery.
Participating in another study.
Pregnancy and lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of device- and procedure-related adverse events intra-operatively,<br /><br>and through two years follow-up.<br /><br>Average CMC-I joint pain score post-procedure compared to pre-operative<br /><br>baseline through two years follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change in pain medication use for CMC-I joint as compared to baseline.<br /><br>Change in CMC-I joint function post-procedure as compared to baseline.<br /><br>Change in DASH scores as compared to baseline</p><br>