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NCT Number: NCT05127005

Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb

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.

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Key information

Conditions

Thumb Osteoarthritis

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital, Helsinki, Finland

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About this study

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 (CMC1). The primary outcome is Patient Reported Wrist and Hand Evaluation (PRWHE) at 6 months after the randomization to treatment group. Secondary measures include PRWHE at 3 months, 1 year, 2 years and 5 years, grip strength, and global assessment of change.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trapeziectomy

Procedure

Surgical excision of trapezoideum

Sham

Procedure

Skin incision only

Primary outcomes

  1. Patient reported wrist and hand evaluation (PRWHE)

    Time frame: 6 months

    PROM questionnaire

Secondary outcomes

  1. Patient reported wrist and hand evaluation (PRWHE)

    Time frame: 3 months, and 1, 2, 5 years

    PROM questionnaire

  2. Global improvement

    Time frame: 3 and 6 months, and 1, 2, and 5 years

    PROM, question (Likert scale)

  3. Patient accepted symptom state

    Time frame: 3 and 6 months, and 1, 2, and 5 years

    PROM, question (Likert scale)

  4. Grip and pinch strength

    Time frame: 6 months

    Measured with dynamometer

  5. EUROQOL EQ-5D-5L

    Time frame: 3 and 6 months, and 1, 2, and 5 years

    PROM, health-related quality of life questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Jarkko Jokihaara

CONTACT

[email protected]

+3583311611

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Central Finland Hospital District
  • Helsinki University Central Hospital
  • University of Eastern Finland

Registry information

Official study title

A Multi-center, Investigator-blinded, Randomized, Parallel Group, Superiority Study to Compare the Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb

Acronym: FINTASY

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Nov 19, 2021
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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