Thumb Basal Joint (CMC I) Arthritis - Preoperative Anxiety/Depression, Outcome Instruments, Carpal Cinematics and Cost-utility

NCT ID: NCT04826380

Last Updated: 2021-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2025-04-01

Brief Summary

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A project aiming to promote evidence based practice when treating thumb basal joint (CMC I) arthritis. We will aim to: 1) provide the minimal clinical difference of two general outcome instruments, 2) evaluate the association between pre-operative anxiety and/or depression and outcomes following trapeziectomy, 3) evaluate the effect of trapziectomy on carpal cinematics, 4) determine the cost-utility-ratio of trapeziectomy

Detailed Description

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Conditions

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Arthritis Thumb Osteoarthritis Arthropathy Quality of Life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trapeziectomy

Simple trapeziectomy for treating CMC I arthritis

Group Type OTHER

Trapeziectomy

Intervention Type PROCEDURE

Simple trapeziectomy (without LRTI)

Conservative

Conservative measures (e.g. splint, NSAID, activation modification) for treating CMC I arthritis

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Trapeziectomy

Simple trapeziectomy (without LRTI)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Eaton-Glickel \>2 arhritis
* Symptom duration \>3 months
* Pain VAS \>30mm
* No significant comorbidities, ASA I-II
* Fluent in Finnish language

Exclusion Criteria

* Eaton-Glickel \<2
* Duration of symptoms \<3 months
* VAS \<30mm
* ASA \>II
* Inflammatory joint disease
* Systemic corticosteroid or immunomodulatory medication
* Upper limb symptoms not explained with CMC I artritis
* Heavy smoking (\> 20 cigarettes per day)
* Alcohol or drug abuse
* Neurological condition affecting upper limb function
* Other ipsilateral upper limb condition requiring surgery
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Töölö Hospital

OTHER

Sponsor Role lead

Responsible Party

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Samuli Aspinen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Töölö Hospital (Helsinki University Hospital)

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Samuli Aspinen, M.D., Ph.D.

Role: CONTACT

+358406360546

Facility Contacts

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Samuli Aspinen, M.D., Ph.D.

Role: primary

+358406360546

Other Identifiers

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3163/2020

Identifier Type: -

Identifier Source: org_study_id

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