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

RecruitingNAAges 45 Years - anyAllTampere University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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 2. 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. 3. Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain) 4. Age \> 45 years 5. ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System) 6. Ability to speak, understand and read in the language of the clinical site 7. Provision of informed consent from the participant Exclusion Criteria: 1. 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 2. Neurologic condition affecting the function or symptoms of the upper extremity 3. \<6 months from other surgical procedure of the upper extremities 4. Rheumatoid arthritis or other inflammatory joint disease 5. Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides 6. Previous operation due tothumb basal joint (CMC1) osteoarthritis for either side 7. \>45 degrees of hyperextension in the thumb MP joint in resting position (zig zag deformity) 8. Patient is unable to continue his/her current job due to thumb pain
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What it tests

  • Trapeziectomy
  • Sham
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Where

4 sites
Helsinki University Central Hospital
Helsinki, Finland
Central Finland Central Hospital
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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