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Recruiting NCT05127005

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

No phase Interventional Thumb Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trapeziectomy, Sham.
Who it may be relevant to
Registry conditions: Thumb Osteoarthritis. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Trapeziectomy
    Surgical excision of trapezoideum
  • Procedure Sham
    Skin incision only

Primary outcome measures

  • Patient reported wrist and hand evaluation (PRWHE) [Time frame: 6 months]
Secondary outcome measures (5)
  • Patient reported wrist and hand evaluation (PRWHE) [Time frame: 3 months, and 1, 2, 5 years]
  • Global improvement [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • Patient accepted symptom state [Time frame: 3 and 6 months, and 1, 2, and 5 years]
  • Grip and pinch strength [Time frame: 6 months]
  • EUROQOL EQ-5D-5L [Time frame: 3 and 6 months, and 1, 2, and 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Finland · 4 centers
  • Helsinki University Central Hospital — Helsinki
  • Central Finland Central Hospital — Jyväskylä
  • Kuopio University Hospital — Kuopio
  • Tampere University Hospital — Tampere

Identifiers

NCT: NCT05127005 · TAUH_FINTASY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗