Patients with a carpometacarpal (CMC) I arthroplasty vs a resection-suspension-interposition (RSI) arthroplasty Surgery
Conditions
Interventions
Questionnaires and medical costs will be analysed to evaluate the cost-utility of the Touch implant in patients compared to a RSI arthroplasty. As comparison group, the researchers will use outcome da
Sponsors
Schulthess-Klinik
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent as documented by signature 2. Patient is diagnosed with primary osteoarthritis (OA) at the thumb carpometacarpal (CMC I) joint and will be operated with a Touch® prosthesis (typically on average 62.9 [±8] years old) 3. Patient is working in Switzerland and intends to continue doing so for at least the duration of their study participation (1 year, i.e. no retirement, sabbatical) 4. Comparison group: Patients who received a resection arthroplasty in a previous study (KEK-ZH Nr. 2013-0381) and had an occupation at that time
Exclusion criteria
Exclusion criteria: 1. Patient with any type of revision surgery at the CMC I joint 2. Patient with rheumatoid arthritis 3. Patient has an additional surgery in the same session (except for simultaneous trigger finger release at the thumb) 4. Non-working patients 5. Legal incompetence 6. German or English language barrier which prevents the participant from completing the questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cost-utility of the Touch® compared to the RSI arthroplasty in terms of an acceptable incremental cost-effectiveness ratio (ICER): 1. Costs will comprise of direct medical costs that have accrued due to the operation until 1 year after surgery, taken from the clinic's billing system 2. Indirect costs associated with loss of productivity measured with the Work Productivity and Activity Impairment Questionnaire (WPAI) at baseline, 6 weeks, 3 months, 6 months and 1 year after surgery 3. Utilities (quality-adjusted life years) will be derived from the EuroQol EQ-5D five-level (EQ-5D-5L) questionnaire at baseline, 6 weeks, 3 months, 6 months and 1 year after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 6 weeks, 3 months and 1 year after surgery: 1. Range of motion (flexion-extension of the MCP and thumb interphalangeal joint) measured using a goniometer 2. Thumb opposition measured using the Kapandji scoring system 2. Grip strength measured with a JAMAR dynamometer and key pinch strength measured with a pinch gauge 3. Hand function measured using the Brief Michigan Hand Outcomes Questionnaire (brief MHQ) 4. Pain scores at rest and during daily activities measured using a Numeric Rating Scale (NRS, o = no pain, 10 = worst pain) 5. Satisfaction measured using a questionnaire (e.g. How is your operated thumb in general compared to before the surgery?) 6. Physical work demands measured using a questionnaire (e.g. Do you have to use your hands a lot during your regular work?) | — |
Countries
Switzerland
Outcome results
None listed