Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorTampere University Hospital

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

132 Participants
are divided into 3 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