Actively Recruiting
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Led by Tampere University Hospital · Updated on 2022-01-21
132
Participants Needed
4
Research Sites
410 weeks
Total Duration
On this page
Sponsors
T
Tampere University Hospital
Lead Sponsor
H
Helsinki University Central Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 osteoarthritis after insufficient benefit from non-operative treatment including thumb orthosis and pain medication used for at least three months
- Thumb pain of at least 4 on a 0 to 10 numerical rating scale when in use
- Age over 45 years
- ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System)
- Ability to speak, understand, and read the language of the clinical site
- Provision of informed consent
You will not qualify if you...
- Main complaint due to other problems than primary thumb basal joint osteoarthritis or planned other surgery along with trapeziectomy
- Neurologic condition affecting function or symptoms of the upper extremity
- Less than 6 months since other surgical procedure on the upper extremities
- Rheumatoid arthritis or other inflammatory joint disease
- Bilateral thumb basal joint osteoarthritis where patient requests treatment for both sides
- Previous surgery for thumb basal joint osteoarthritis on either side
- More than 45 degrees hyperextension in the thumb MP joint at rest (zig zag deformity)
- Unable to continue current job due to thumb pain
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Helsinki University Central Hospital
Helsinki, Finland
Actively Recruiting
2
Central Finland Central Hospital
Jyväskylä, Finland
Actively Recruiting
3
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
4
Tampere University Hospital
Tampere, Finland
Actively Recruiting
Research Team
J
Jarkko Jokihaara
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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