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

Not Applicable

Recruiting

• Conditions: Thumb Osteoarthritis
• Interventions: Procedure: Trapeziectomy; Procedure: Sham

• Registration Number: NCT05127005
• Lead Sponsor: Tampere University Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-11-19
• Status Verified: 2022-01
• Study Start: 2022-01-20
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-21
• Primary Completion: 2024-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trapeziectomy	Trapeziectomy	Trapeziectomy
Non-randomized observational arm	Trapeziectomy	Non-randomized observational arm (trapeziectomy, not blinded)
Sham surgery	Sham	Sham surgery

Primary Outcome Measures

Name	Time	Method
Patient reported wrist and hand evaluation (PRWHE)	6 months	PROM questionnaire

Secondary Outcome Measures

Name	Time	Method
Patient accepted symptom state	3 and 6 months, and 1, 2, and 5 years	PROM, question (Likert scale)
Grip and pinch strength	6 months	Measured with dynamometer
Patient reported wrist and hand evaluation (PRWHE)	3 months, and 1, 2, 5 years	PROM questionnaire
EUROQOL EQ-5D-5L	3 and 6 months, and 1, 2, and 5 years	PROM, health-related quality of life questionnaire
Global improvement	3 and 6 months, and 1, 2, and 5 years	PROM, question (Likert scale)

Trial Locations

Locations (4)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland