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

Launched by TAMPERE UNIVERSITY HOSPITAL · Nov 18, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a surgical procedure called trapeziectomy compared to a sham (placebo) surgery for people suffering from osteoarthritis at the base of the thumb. Osteoarthritis is a common condition that causes pain and stiffness in the joints, and in this case, it affects the thumb joint, making everyday activities difficult. The trial aims to find out how well trapeziectomy relieves pain and improves hand function over a six-month period.

To be eligible for this trial, participants should be over 45 years old and have been experiencing moderate to severe thumb pain (rated 4 or higher on a scale of 0 to 10) that hasn't improved with non-surgical treatments like medication or wearing a thumb brace for at least three months. Participants will need to commit to attending regular follow-up visits to assess their pain and hand function. This trial is currently recruiting and welcomes individuals of all genders who meet the criteria, as long as they can understand the study information and give their consent to participate.

Gender

ALL

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