Rizarthrosis thumb arthritis
Conditions
Interventions
Sponsors
Articulinx Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of device- and procedure-related adverse events intra-operatively, and through two years follow-up. Average CMC-I joint pain score post-procedure compared to pre-operative baseline through two years follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pain medication use for CMC-I joint as compared to baseline. Change in CMC-I joint function post-procedure as compared to baseline. Change in DASH scores as compared to baseline | — |
Countries
Netherlands
Outcome results
None listed