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.
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
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.
Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain)
Age > 45 years
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
Neurologic condition affecting the function or symptoms of the upper extremity
<6 months from other surgical procedure of the upper extremities
Rheumatoid arthritis or other inflammatory joint disease
Parallel
Trapeziectomy
Procedure/SurgerySurgical excision of trapezoideum
Sham
Procedure/SurgerySkin incision only
Patient reported wrist and hand evaluation (PRWHE)
PROM questionnaire
Patient reported wrist and hand evaluation (PRWHE)
PROM questionnaire
Global improvement
PROM, question (Likert scale)
Patient accepted symptom state
PROM, question (Likert scale)
Grip and pinch strength
Measured with dynamometer
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Tampere University Hospital
Lead sponsor
Helsinki University Central Hospital
Collaborator
Central Finland Hospital District
Collaborator
University of Eastern Finland
Collaborator
