Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Recruiting · NCT05127005 · Interventional (participants receive a specific treatment) · Lead sponsor: Tampere University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
ShamTrapeziectomy
What this trial is about
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 take part
Age range
45 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- 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
Where it is running
4 locations listed.
- Helsinki University Central Hospital - Helsinki, Finland
- Central Finland Central Hospital - Jyväskylä, Finland
- Kuopio University Hospital - Kuopio, Finland
- Tampere University Hospital - Tampere, Finland