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Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus

Primary Purpose

Hallux Rigidus

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Use of a rehabilitation brace
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Rigidus

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hallux rigidus Exclusion Criteria: -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Mobility of the big toe joint

    Secondary Outcome Measures

    Full Information

    First Posted
    January 30, 2006
    Last Updated
    July 1, 2021
    Sponsor
    University Hospital, Ghent
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00284284
    Brief Title
    Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus
    Official Title
    Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Ghent

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Comparison of the added value of a rehabilitation brace to standard rehabilitation by physiotherapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hallux Rigidus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Use of a rehabilitation brace
    Primary Outcome Measure Information:
    Title
    Mobility of the big toe joint

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hallux rigidus Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rene Verdonk, MD, PhD
    Organizational Affiliation
    University Hospital, Ghent
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.uzgent.be
    Description
    Website University Hospital Ghent

    Learn more about this trial

    Investigation of the Added Value of a Big Toe Hinged Brace for the Treatment of Hallux Rigidus

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