Actively Recruiting

Phase Not Applicable
Age: 45Years +
All Genders
Healthy Volunteers
NCT05127005

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

Age: 45Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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