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

Elsan130 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

130

Conditions

Ankle Sprains Ligament Sprain

Interventions

Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical testsOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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)

Time frame: At 6 months post-intervention

Secondary Outcomes

The composite score's sensibility to change (ability of the composite score to measure patients' progress)

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

Time frame: At 4 months, 6 months and 1 year post-intervention

Reproductibility of the composite score

The reproductibility of the composite score will be measured by Analysis of composite score results at 24 hours interval.

Time frame: At 6 months with interval of + 24 hours

Discriminating ability of the composite score

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