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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Surgical excision of trapezoideum
Skin incision only
Helsinki University Central Hospital
Helsinki, Finland
RECRUITINGCentral Finland Central Hospital
Jyväskylä, Finland
RECRUITINGKuopio University Hospital
Kuopio, Finland
RECRUITINGPatient reported wrist and hand evaluation (PRWHE)
PROM questionnaire
Time frame: 6 months
Patient reported wrist and hand evaluation (PRWHE)
PROM questionnaire
Time frame: 3 months, and 1, 2, 5 years
Global improvement
PROM, question (Likert scale)
Time frame: 3 and 6 months, and 1, 2, and 5 years
Patient accepted symptom state
PROM, question (Likert scale)
Time frame: 3 and 6 months, and 1, 2, and 5 years
Grip and pinch strength
Measured with dynamometer
Time frame: 6 months
EUROQOL EQ-5D-5L
PROM, health-related quality of life questionnaire
Time frame: 3 and 6 months, and 1, 2, and 5 years
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Tampere University Hospital
Tampere, Finland
RECRUITING