Comparing trapeziectomy to sham surgery for thumb osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of trapeziectomy, a surgical procedure, compared to a sham surgery in patients suffering from painful osteoarthritis at the base of the thumb. It is a multi-center, randomized, placebo-controlled trial that focuses on patient-reported outcomes, specifically pain and function of the wrist and hand, measured at 6 months post-treatment. Secondary outcomes include assessments at 3 months, 1 year, 2 years, and 5 years, as well as grip strength and overall change in condition. The study aims to provide robust data on the benefits of surgical intervention for this condition.

Why it matters

Who can join: the full rules

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
8. Shared decision to proceed with surgical treatment of CMC-1 OA

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

Where it's running

• Helsinki University Central Hospital
  Helsinki, Finland Recruiting
• Central Finland Hospital Nova
  Jyväskylä, Finland Recruiting
• Kuopio University Central Hospital
  Kuopio, Finland Recruiting
• Tampere University Hospital
  Tampere, Finland Recruiting

Study contacts

• Study coordinator: Jarkko Jokihaara
• Email: jarkko.jokihaara@pirha.fi
• Phone: +3583311611

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Thumb base arthritis: joint replacement vs trapeziectomy

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  Recruiting Uppsala University · Uppsala · NCT07569549

• High-energy laser treatment for thumb osteoarthritis (rhizarthrosis)

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• PRP Injection for Thumb Base Osteoarthritis (CMC-I) to See if It Reduces Pain

  A PRP injection into the thumb base joint is being tested against a saline injection to see if it lowers pain and improves hand function for adults with thumb base osteoarthritis.

  Recruiting Phase 2 Goed Medisch Centrum · Breda, North Brabant · NCT07491302

• ICF-based biopsychosocial hand OA assessment with AI profile prediction

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• Comparing NSAID and corticosteroid injections for thumb arthritis treatment

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• Comparing different immobilization durations after thumb joint surgery

  This study tests whether keeping the thumb in a cast for 2 weeks or 6 weeks after surgery helps people with thumb arthritis heal better and recover faster.

  Recruiting University of Chicago · Chicago, Illinois · NCT04828954

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.