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

Thumb Osteoarthritis Clinical Trial

— FINTASY  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05127005
• Other study ID #: TAUH_FINTASY
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: December 2029

Study information

• Verified date: January 2022
• Source: Tampere University Hospital
• Contact: Jarkko Jokihaara
• Phone: +3583311611
• Email: jarkko.jokihaara[@]pshp.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 2029
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Central Finland Central Hospital	Jyväskylä
Finland	Kuopio University Hospital	Kuopio
Finland	Tampere University Hospital	Tampere

Sponsors (4)

Lead Sponsor	Collaborator
Tampere University Hospital	Central Finland Central Hospital, Helsinki University Central Hospital, University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

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