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

Tampere University Hospital

Status: Enrolling

Conditions: Thumb Osteoarthritis

Treatments: Procedure: Sham; Procedure: Trapeziectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05127005

TAUH_FINTASY

Details and patient eligibility

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 3 patient groups

Trapeziectomy

Experimental group

Description:

Trapeziectomy

Treatment:

Procedure: Trapeziectomy

Sham surgery

Sham Comparator group

Description:

Sham surgery

Treatment:

Procedure: Sham

Non-randomized observational arm

Other group

Description:

Non-randomized observational arm (trapeziectomy, not blinded)

Treatment:

Procedure: Trapeziectomy