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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Thumb Osteoarthritis

In brief

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.

Key facts

Study ID

NCT05127005

Run by

Tampere University Hospital

People needed

132

Starts

2022-01-20

Expected to finish

2029-12-01

Last updated by the study team

2022-01-21

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System)
• Ability to speak, understand and read in the language of the clinical site
• Provision of informed consent from the participant

You may not qualify if…

• 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
• Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides
• Previous operation due tothumb basal joint (CMC1) osteoarthritis for either side
• >45 degrees of hyperextension in the thumb MP joint in resting position (zig zag deformity)
• Patient is unable to continue his/her current job due to thumb pain

Where it is running

• Helsinki University Central Hospital — Helsinki, Finland (enrolling)
• Central Finland Central Hospital — Jyväskylä, Finland (enrolling)
• Kuopio University Hospital — Kuopio, Finland (enrolling)
• Tampere University Hospital — Tampere, Finland (enrolling)

Full record on ClinicalTrials.gov

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