Comparing trapeziectomy to sham surgery for thumb osteoarthritis
A Multi-center, Investigator-blinded, Randomized, Parallel Group, Superiority Study to Compare the Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
This study is testing whether a thumb surgery called trapeziectomy can help people with painful thumb arthritis feel better compared to a fake surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 4 sites (Helsinki and 3 other locations) |
| Trial ID | NCT05127005 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of trapeziectomy, a surgical procedure, compared to a sham surgery in patients suffering from painful osteoarthritis at the base of the thumb. It is a multi-center, randomized, placebo-controlled trial that focuses on patient-reported outcomes, specifically pain and function of the wrist and hand, measured at 6 months post-treatment. Secondary outcomes include assessments at 3 months, 1 year, 2 years, and 5 years, as well as grip strength and overall change in condition. The study aims to provide robust data on the benefits of surgical intervention for this condition.
Who should consider this trial
Good fit: Ideal candidates are individuals over 45 years old with confirmed Eaton Glickel grade 2 or higher thumb osteoarthritis who have not found relief from non-surgical treatments.
Not a fit: Patients whose primary complaint is due to conditions other than thumb basal joint osteoarthritis or those requiring concurrent surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated surgical option for patients suffering from debilitating thumb osteoarthritis, improving their quality of life.
How similar studies have performed: Previous studies have shown varying success with surgical interventions for osteoarthritis, but this specific comparison of trapeziectomy to sham surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Helsinki and 3 other locations
- Helsinki University Central Hospital — Helsinki, Finland (Recruiting)
- Central Finland Central Hospital — Jyväskylä, Finland (Recruiting)
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
Study contacts
- Study coordinator: Jarkko Jokihaara
- Email: jarkko.jokihaara@pshp.fi
- Phone: +3583311611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.