Clinical evaluation of the Articulinx Implant for the Carpometacarpal Joint.

Completed

• Conditions: Rizarthrosis; thumbarthritis; 10023213

• Registration Number: NL-OMON35298
• Lead Sponsor: Articulinx

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Adults between ages 40-75 with stage I or II osteoarthritis (according to Eaton Littler classification) of the CMC I joint. Subluxation less than 1/3 of the joint. Patients who are capable of providing informed consent and willing to adhere to the follow up schedule.

Exclusion Criteria

Significant and affecting pathology of the radial side of the hand and wrist.
Significant osteophytes of the CMC I joint.
Metabolic disorders of the bone.
Prior surgery that precludes placement.
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.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Average pain score post procedure compared to pre operative baseline.<br /><br>Change in pain medication use ( taken specifically for the hand) compared to<br /><br>pre operative baseline.<br /><br>Change in joint function post procedure compared to pre operative baseline.</p><br>