Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
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
Tampere University Hospital
132 participants
Jan 20, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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
Exclusion Criteria8
- 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
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Interventions
Surgical excision of trapezoideum
Skin incision only
Locations(4)
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NCT05127005