NCT02508233

Brief Summary

Many recent randomised multi-centre trials have used the AOS and the involvement of the French-speaking population is limited by the absence of a French version. The goal of our study was to develop a French version and validate the psychometric properties to assure equivalence to the English original.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
Last Updated

July 24, 2015

Status Verified

July 1, 2015

Enrollment Period

5.3 years

First QC Date

July 22, 2015

Last Update Submit

July 22, 2015

Conditions

Outcome Measures

Primary Outcomes (3)

  • Reliability

    test-retest of AOS-Fr

    1 week

  • Criterion validity

    Correlation of AOS-Fr and SF-36 and WOMAC scores

    1 day

  • Construct validity

    Correlation of AOS-Fr and single heel-lift

    1 day

Study Arms (2)

Control

Healthy subjects (without ankle osteoarthritis) for validation of translation

ankle OA

Ankle osteoarthritis patients to ensure validity of translated scale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The "Test of the Pre-final version" will be performed using subjects with no ankle osteoarthritis who will answer the questionnaire and evaluate their comprehension of each item. Patients with isolated ankle degenerative changes at the orthopaedic outpatient clinic of the Centre Hospitalier Universitaire de Sherbrooke (CHUS) will be used to validate the questionnaire. Patients have to consider French as their mother tongue and be able to read and write in French. Patients under 18 years old and those with additional foot and/or ankle pathologies will be excluded.

You may qualify if:

  • years of age and over
  • French as their mother tongue
  • able to read and write in French

You may not qualify if:

  • foot and/or ankle pathologies
  • OA group
  • years of age and over
  • isolated ankle degenerative changes
  • French as their mother tongue
  • able to read and write in French
  • additional foot and/or ankle pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Frédéric Balg, MD

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR
  • Magalie Angers, MD

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic surgeon

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 24, 2015

Study Start

September 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 24, 2015

Record last verified: 2015-07