Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty

March 28, 2024 updated by: Elsan

Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty - Ankle Go Study

The goal of this prospective, open label study is the construction and the evaluation of a composite score evaluating the residual instability in patients who have undergone an ankle's ligamentoplasty (the Ankle Go Test score).

The main hypothesis of this study is based on the fact that the composite score "Ankle Go Test" would allow a global validation of all the criteria of scores of 4 tests and 2 questionnaires, which are performed in common pratice, evaluating the instability of the ankle after an ankle ligamentoplasty.

Participants will have to complete 2 questionnaires (FAAM, ALR RS) and to undergoe 4 tests (Single Leg Stance Test, Side Hop Test, Start Excursion Balance Test, La figure of 8), at 4, 6 and 12 months post surgery.

Researchers will compare the group of participants who undergone ankle's ligamentoplasty with a group of healthy volunteers to assess the discriminant validity of the Ankle Go Test score

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44800
        • Santé Atlantique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male and female patients who underwent arthroscopic ankle ligamentoplasty or healthy volunteers with no previous knee or ankle history.
  2. Age ≥ 18 years
  3. Patients who's been informed about the study and who didn't express their opposition to participate

Exclusion Criteria:

  1. Patients with chronic ankle instability, operated or not, contralateral
  2. Patients under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group of the construction of the composite Ankle go score and internal validations
50 patients will be include for the construction of the composite score and its internal validations. They will complete questionnaires (FAAM, ALR-RSI) and undergo tests (SLSTS, SHTS, SEBT and Figure of 8) 4 months after ankle's surgery (visit 1), 6 months after surgery (visit 2) and 12 months post surgery
Other: Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests

Four tests and two questionnaires, each evaluating specific physical or psychological dimensions will be used to construct the composite score "Ankle Go Test" composite score:

  • Foot and Ankle Ability Measure Questionnaire (FAAM)
  • Ankle ligament reconstruction-return to sport after injury Questionnaire(ALR-RSI)
  • Single Leg Stance Test (SLST)
  • Side Hop Test (SHT)
  • Star Excursion Balance Test (SEBT)
  • Figure-of-8
Experimental: group of the external validation stage of the composite score
50 additional patients for the external validation stage of the composite score. They will complete questionnaires (FAAM, ALR-RSI) and undergo tests (SLSTS, SHTS, SEBT and Figure of 8) 4 months after ankle's surgery (visit 1) and 6 months after surgery (visit 2)
Other: Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests

Four tests and two questionnaires, each evaluating specific physical or psychological dimensions will be used to construct the composite score "Ankle Go Test" composite score:

  • Foot and Ankle Ability Measure Questionnaire (FAAM)
  • Ankle ligament reconstruction-return to sport after injury Questionnaire(ALR-RSI)
  • Single Leg Stance Test (SLST)
  • Side Hop Test (SHT)
  • Star Excursion Balance Test (SEBT)
  • Figure-of-8
No Intervention: Group allowing the assessment of the score's ability to discriminate
30 healthy volunteers (who did not undergone an ankle's surgery) will be included in the study to analyze the ability of composite score to discriminate. The healthy population will perform the same physical and psychological tests as Group allowing the construction of the composite Ankle go score and internal validations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The construction of the " Ankle Go Test ", composed of the scores obtained from the 4 tests and 2 questionnaires perfomed 6 months post ankle's surgery
Time Frame: At 6 months post-intervention

Three steps will be required to construct the "Ankle Go Test":

  • Determining how much information the tests and questionnaires will contribute to the overall composite score (step 1)
  • Construction of the score itself and extraction of a residual instability cut-off by the patient at 6 months post-intervention (step 2).
  • Confirmation of the weighting and validation of the composite score and the cut-off using an external population (external validation; step 3)
At 6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The composite score's sensibility to change (ability of the composite score to measure patients' progress)
Time Frame: At 4 months, 6 months and 1 year post-intervention
The ability of the composite score to measure patients' progress will be measured by analysis of composite score results at 4 months, 6 months and 1 year post surgery
At 4 months, 6 months and 1 year post-intervention
Reproductibility of the composite score
Time Frame: At 6 months with interval of + 24 hours
The reproductibility of the composite score will be measured by Analysis of composite score results at 24 hours interval.
At 6 months with interval of + 24 hours
Discriminating ability of the composite score
Time Frame: At 6 months post-intervention
Discriminating ability of the composite score will be measured by the Comparison of the composite score's results in post-operative patients to composite score's results in healthy volunteers
At 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ankle Go study
  • 2021-A03239-32 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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