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

Primary Purpose

Thumb Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Trapeziectomy
Sham
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thumb Osteoarthritis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Helsinki University Central HospitalRecruiting
  • Central Finland Central HospitalRecruiting
  • Kuopio University HospitalRecruiting
  • Tampere University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Trapeziectomy

Sham surgery

Non-randomized observational arm

Arm Description

Trapeziectomy

Sham surgery

Non-randomized observational arm (trapeziectomy, not blinded)

Outcomes

Primary Outcome Measures

Patient reported wrist and hand evaluation (PRWHE)
PROM questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2021
Last Updated
January 20, 2022
Sponsor
Tampere University Hospital
Collaborators
Helsinki University Central Hospital, Central Finland Central Hospital, University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT05127005
Brief Title
Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
Collaborators
Helsinki University Central Hospital, Central Finland Central Hospital, University of Eastern Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trapeziectomy
Arm Type
Experimental
Arm Description
Trapeziectomy
Arm Title
Sham surgery
Arm Type
Sham Comparator
Arm Description
Sham surgery
Arm Title
Non-randomized observational arm
Arm Type
Other
Arm Description
Non-randomized observational arm (trapeziectomy, not blinded)
Intervention Type
Procedure
Intervention Name(s)
Trapeziectomy
Intervention Description
Surgical excision of trapezoideum
Intervention Type
Procedure
Intervention Name(s)
Sham
Intervention Description
Skin incision only
Primary Outcome Measure Information:
Title
Patient reported wrist and hand evaluation (PRWHE)
Description
PROM questionnaire
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient reported wrist and hand evaluation (PRWHE)
Description
PROM questionnaire
Time Frame
3 months, and 1, 2, 5 years
Title
Global improvement
Description
PROM, question (Likert scale)
Time Frame
3 and 6 months, and 1, 2, and 5 years
Title
Patient accepted symptom state
Description
PROM, question (Likert scale)
Time Frame
3 and 6 months, and 1, 2, and 5 years
Title
Grip and pinch strength
Description
Measured with dynamometer
Time Frame
6 months
Title
EUROQOL EQ-5D-5L
Description
PROM, health-related quality of life questionnaire
Time Frame
3 and 6 months, and 1, 2, and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jarkko Jokihaara
Phone
+3583311611
Email
jarkko.jokihaara@pshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarkko Jokihaara
Organizational Affiliation
TAUH
Official's Role
Study Chair
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eero Waris
Facility Name
Central Finland Central Hospital
City
Jyväskylä
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teemu Karjalainen
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yrjänä Nietosvaara
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarkko Jokihaara

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
In this trial IPD sharing is restricted by data protection regulations

Learn more about this trial

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

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