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

NCT05127005 | Recruiting DMC

• 1 other identifier: TAUH_FINTASY
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 4

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.

Conditions

Thumb Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Patient reported wrist and hand evaluation (PRWHE)

  PROM questionnaire

  6 months

Secondary Outcomes (5)

• Patient reported wrist and hand evaluation (PRWHE)

  3 months, and 1, 2, 5 years

• Global improvement

  3 and 6 months, and 1, 2, and 5 years

• Patient accepted symptom state

  3 and 6 months, and 1, 2, and 5 years

• Grip and pinch strength

  6 months

• EUROQOL EQ-5D-5L

  3 and 6 months, and 1, 2, and 5 years

Study Arms (3)

Trapeziectomy

EXPERIMENTAL

Trapeziectomy

Procedure: Trapeziectomy

Sham surgery

SHAM COMPARATOR

Sham surgery

Procedure: Sham

Non-randomized observational arm

OTHER

Non-randomized observational arm (trapeziectomy, not blinded)

Procedure: Trapeziectomy

Interventions

Trapeziectomy PROCEDURE

Surgical excision of trapezoideum

Non-randomized observational arm; Trapeziectomy

Sham PROCEDURE

Skin incision only

Sham surgery

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Helsinki University Central Hospital: collaborator
• Central Finland Central Hospital: collaborator
• University of Eastern Finland: collaborator

Study Sites (4)

Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

Central Finland Central Hospital

Jyväskylä, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Jarkko Jokihaara

  TAUH

  STUDY CHAIR

Central Study Contacts

Jarkko Jokihaara

CONTACT

+3583311611; jarkko.jokihaara@pshp.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: November 19, 2021
• Study Start: January 20, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (4)