Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of t… (NCT05127005) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Finland132 participantsStarted 2022-01-20
Plain-language 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.
Who can participate
Age range45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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
✕
What they're measuring
1
Patient reported wrist and hand evaluation (PRWHE)