NCT05127005 Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
| NCT ID | NCT05127005 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere University Hospital |
| Condition | Thumb Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2022-01-20 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2022-01-20 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Jarkko Jokihaara
STUDY CHAIR
TAUH
Frequently Asked Questions
Who can join the NCT05127005 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Thumb Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05127005 currently recruiting?
Yes, NCT05127005 is actively recruiting participants. Contact the research team at jarkko.jokihaara@pshp.fi for enrollment information.
Where is the NCT05127005 trial being conducted?
This trial is being conducted at Helsinki, Finland, Jyväskylä, Finland, Kuopio, Finland, Tampere, Finland.
Who is sponsoring the NCT05127005 clinical trial?
NCT05127005 is sponsored by Tampere University Hospital. The principal investigator is Jarkko Jokihaara at TAUH. The trial plans to enroll 132 participants.