Efficacy of Trapeziectomy Versus Sham Surgery in the Trea... | NCT05127005

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

NCT05127005

Sponsor

Tampere University Hospital

Status

Recruiting

Last Update Posted

Jan 21, 2022Actual

Enrollment

132Estimated

Phase

Not Applicable

Conditions

Thumb Osteoarthritis

Interventions

Trapeziectomy
Sham

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2022Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Nov 18, 2021

First Submission Date that Met QC Criteria

Nov 18, 2021

First Posted Date

Nov 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2022

Last Update Posted Date

Jan 21, 2022Actual

Name	Class
Helsinki University Central Hospital	OTHER
Central Finland Hospital District	OTHER
University of Eastern Finland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Trapeziectomy	Procedure	Surgical excision of trapezoideum	Non-randomized observational arm Trapeziectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Jarkko Jokihaara	Contact	+3583311611		jarkko.jokihaara@pshp.fi

Name	Affiliation	Role
Jarkko Jokihaara	TAUH	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital	Recruiting	Helsinki			Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

In this trial IPD sharing is restricted by data protection regulations

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided