Thumb Osteoarthritis
Conditions
Brief summary
A randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.
Interventions
PROCEDUREtrapeziometacarpal limited excision
Narrow pseudarthrosis CMC1
PROCEDURETrapeziectomy
Simple trapeziectomy
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test). * Pain at rest. * Conservative treatment \>6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection)
Exclusion criteria
* Rheumatoid arthritis. * Ongoing infection in the hand or wrist. - * History of gout or pseudo gout. * Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). * Intra-articular injection in the affected joint within 6 months. * Eaton Littler class 4 (STT joint involved).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain on load NRS (numerical rating scale) | Preoperatively, 1, 3 and 5 years postoperatively | Change in rated pain on load from preoperatively to 1, 3 and 5 years postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nelson Thumb score | Preoperatively, 1, 3 and 5 years postoperatively | 0-100 p, higher score = less disability |
| Change in EQ-5D | 1, 3 and 5 years postoperatively | Weight mean value: 0=dead, 1= healthy |
| Change in DASH - Disability of the Arm, Shoulder and Hand | Preoperatively, 1, 3 and 5 years postoperatively | 0-100 p, higher score = more disability |
| Change in PRWHE - Patient-Rated Wrist and Hand Evaluation | Preoperatively, 1, 3 and 5 years postoperatively | 0-100 p, higher score = more disability |
| Change in HADS - Change hospital Anxiety and Depression score | Preoperatively, 1, 3 and 5 years postoperatively | 2 subscores for anxiety (0-21P) and depression (0-21p), higher score = worse |
| Change in PCS - Pain Catastrophizing Score | Preoperatively, 1, 3 and 5 years postoperatively | 0-52, higher score = more pain catastrophizing |
| Change in Thumb base motion | Preoperatively, 1, 3 and 5 years postoperatively | radial and palmar abduction of the first metacarpal (degrees). |
| Change in thumb strength | Preoperatively, 1, 3 and 5 years postoperatively | Key pinch and pinch strength (Kg) |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORMaria Wilcke, MD PhD
Karolinska Instituet
Outcome results
None listed