Rizarthrosis thumbarthritis
Conditions
Interventions
Sponsors
Articulinx
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of device and procedure related adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Average pain score post procedure compared to pre operative baseline. Change in pain medication use ( taken specifically for the hand) compared to pre operative baseline. Change in joint function post procedure compared to pre operative baseline. | — |
Countries
Netherlands
Outcome results
None listed