arthrosis of the thumb base joint Thumb CMC arthrosis Arthritis in the joint at the base of the thumb
Conditions
Interventions
The intervention is a hemiarthroplasty with the InDx implant, instead of a
trapeziectomy. The subjects would have been scheduled for a surgical
intervention anyway.
Sponsors
Loci Orthopaedics
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: A. The patient is at least 18 years of age; B. The patient has a confirmed Grade I-III osteoarthritis of the CMC joint on clinical examination and X-ray;
Exclusion criteria
Exclusion criteria: A. The patient is suffering from Rheumatoid arthritis in the index hand; B. The patient is suffering from Grade IV osteoarthritis of the CMC joint; C. The patient is suffering post-traumatic arthritis of the CMC joint in the index hand; D. The patient is a pregnant/lactating female (tested as per institutional requirements); E. Active or latent infection, or sepsis; F. Insufficient quantity or quality of bone and/or soft tissue in the index hand; G. Metal or polymer material sensitivity; H. Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a a poor soft-tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy; I. Patient with previous thumb surgery in the index hand J. In the opinion of the investigator, any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to a. Patients with a diagnosis of concomitant injury that may interfere with healing b. Patients with clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease or systemic infection that may make interpretation of the results difficult K. Patients who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents; L. Comorbidity that reduces life expectancy to less than 36 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: adverse events related to the device which lead to a total revision. Primary endpoint efficacy: outcome functional performance per DASH and PRWHE questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endoints: - Thumb ROM - Pinch force (tip pinch and latral pinch) - Grip force Also see section 4.2 of the CIP. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactK Seldeslagh
KasaConsult
Outcome results
None listed