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Compares treatment options for Thumb Osteoarthritis
Official title Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
ClinicalTrials.gov ID: NCT05127005
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older. Healthy volunteers may be eligible.
You may be able to join if
- Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities...
- Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use...
- 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)
You likely can't join if
- Patients' main complaint is due to some other problem than primary thumb basal joint (CMC1) osteoarthritis or patient will undergo any other surgery...
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
- Jyväskylä, Finland
- Kuopio, Finland
- Tampere, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland; Jyväskylä, Finland; Kuopio, Finland; Tampere, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.