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

Completed

Conditions: Rizarthrosis
thumb arthritis
10023213

Registration Number: NL-OMON38843

Lead Sponsor: Articulinx Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Adults 40 - 75 yrs. old with stage II osteoarthritis of the CMC-1 joint.
DASH score >40.
Average VAS pain score >40 at inclusion.
Subluxation less than 1/3.
Patients capable of providing informed consent.

Exclusion Criteria

Non symptomatic osteoarthritis of the CMC-1 joint.
Significant osteophytes(>2mm diameter) OARSI grade III and/or free floating bodies in the CMC-1 joint.
Radiographic evidence of OA in first MC or STT joint of the hand to be treated.
Concomitant musculoskeletal or Rheumatic pathology in hand to be treated,
Prior surgery affecting the biomechanics in the target wrist within previous 12 months
Corticosteroid injections in the treated joint within previous 3 months
Participation in another study
Pregnancy or lactation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the incidence of unanticipated device and<br /><br>procedure related adverse events intra operatively and through one year follow<br /><br>up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints of this study are:<br /><br>a) Change in joint function post-procedure compared to pre-operative baseline<br /><br>Measurements of contralateral hand function will also be taken at baseline and<br /><br>at subsequent follow-up visits.<br /><br>b) Change in DASH scores post-procedure as compared to pre-operative baseline.<br /><br>c) Maintenance of trapezial joint space height compared to pre-operative<br /><br>baseline.<br /><br>d) the performance of the Articulinx ICMC by evaluating patient reported pain<br /><br>relief in the treated CMC joint through one year following device implantation.</p><br>