Rizarthrosis thumb arthritis
Conditions
Interventions
Sponsors
Articulinx Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the incidence of unanticipated device and procedure related adverse events intra operatively and through one year follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this study are: a) Change in joint function post-procedure compared to pre-operative baseline Measurements of contralateral hand function will also be taken at baseline and at subsequent follow-up visits. b) Change in DASH scores post-procedure as compared to pre-operative baseline. c) Maintenance of trapezial joint space height compared to pre-operative baseline. d) the performance of the Articulinx ICMC by evaluating patient reported pain relief in the treated CMC joint through one year following device implantation. | — |
Countries
Netherlands
Outcome results
None listed