Thumb Osteoarthritis
Conditions
Brief summary
A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.
Detailed description
A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb (CMC1). The primary outcome is Patient Reported Wrist and Hand Evaluation (PRWHE) at 6 months after the randomization to treatment group. Secondary measures include PRWHE at 3 months, 1 year, 2 years and 5 years, grip strength, and global assessment of change.
Interventions
PROCEDURETrapeziectomy
Surgical excision of trapezoideum
PROCEDURESham
Skin incision only
Sponsors
Helsinki University Central Hospital
Central Finland Central Hospital
University of Eastern Finland
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living 2. Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (NSAIDs or paracetamol, implemented for at least three months. 3. Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain) 4. Age \> 45 years 5. ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System) 6. Ability to speak, understand and read in the language of the clinical site 7. Provision of informed consent from the participant
Exclusion criteria
1. Patients' main complaint is due to some other problem than primary thumb basal joint (CMC1) osteoarthritis or patient will undergo any other surgery in conjunction with trapeziectomy 2. Neurologic condition affecting the function or symptoms of the upper extremity 3. \<6 months from other surgical procedure of the upper extremities 4. Rheumatoid arthritis or other inflammatory joint disease 5. Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides 6. Previous operation due tothumb basal joint (CMC1) osteoarthritis for either side 7. \>45 degrees of hyperextension in the thumb MP joint in resting position (zig zag deformity) 8. Patient is unable to continue his/her current job due to thumb pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported wrist and hand evaluation (PRWHE) | 6 months | PROM questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported wrist and hand evaluation (PRWHE) | 3 months, and 1, 2, 5 years | PROM questionnaire |
| Global improvement | 3 and 6 months, and 1, 2, and 5 years | PROM, question (Likert scale) |
| Patient accepted symptom state | 3 and 6 months, and 1, 2, and 5 years | PROM, question (Likert scale) |
| Grip and pinch strength | 6 months | Measured with dynamometer |
| EUROQOL EQ-5D-5L | 3 and 6 months, and 1, 2, and 5 years | PROM, health-related quality of life questionnaire |
Countries
Finland
Contacts
Primary ContactJarkko Jokihaara
Outcome results
None listed