Validation of Patient Reported Outcome Measures for Use in Hallux Valgus

NCT ID: NCT03846687

Last Updated: 2020-01-27

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

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-30

Study Completion Date

2020-01-15

Brief Summary

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The purpose of the study is to explore whether the mFFI is fit for purpose in adults with hallux valgus (HV).

Detailed Description

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Conditions

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Hallux Valgus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male or female, of any race and, aged ≥ 18 years
* Clinical diagnosis of hallux valgus
* Fluent in reading/speaking US-English to read and understand informed consent form and to participate in the interview

Exclusion Criteria

* Participation in another foot-based clinical trial in the last 90 days or in Ipsen's clinical trial D-FR-52120-237
* Current chronic drug or alcohol abuse problem
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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University Foot and Ankle Institute

Santa Monica, California, United States

Site Status

Ankle and Foot Care Centers

Youngstown, Ohio, United States

Site Status

Futuro Clinical Trials, LLC

McAllen, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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D-FR-52120-257

Identifier Type: -

Identifier Source: org_study_id

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