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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Procedure: Trapeziectomy; Procedure: Sham

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 Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jarkko Jokihaara; Phone Number: +3583311611; Email: jarkko.jokihaara@pshp.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Central Hospital
    • Contact: Eero Waris
  • Jyväskylä, Finland
    • Recruiting
    • Central Finland Central Hospital
    • Contact: Teemu Karjalainen
  • Kuopio, Finland
    • Recruiting
    • Kuopio University Hospital
    • Contact: Yrjänä Nietosvaara
  • Tampere, Finland
    • Recruiting
    • Tampere University Hospital
    • Contact: Jarkko Jokihaara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trapeziectomy	Procedure: Trapeziectomy; Surgical excision of trapezoideum
Sham Comparator: Sham surgery	Procedure: Sham; Skin incision only
Other: Non-randomized observational arm; Non-randomized observational arm (trapeziectomy, not blinded)	Procedure: Trapeziectomy; Surgical excision of trapezoideum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported wrist and hand evaluation (PRWHE)	PROM questionnaire	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Helsinki University Central Hospital; University of Eastern Finland; Central Finland Central Hospital
• Investigators: Study Chair: Jarkko Jokihaara, TAUH

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2029

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: TAUH_FINTASY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: In this trial IPD sharing is restricted by data protection regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No