About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Trapeziectomy
- Sham
Treatment groups
Sponsors and collaborators
Tampere University Hospital
Lead sponsor
Helsinki University Central Hospital
Collaborator
Central Finland Hospital District
Collaborator
University of Eastern Finland
Collaborator