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

Not Applicable

Completed

• Conditions: Ligament Sprain; Ankle Sprains
• Interventions: Other: Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests

• Registration Number: NCT05331365
• Lead Sponsor: Elsan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Study Start: 2022-05-12
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group of the construction of the composite Ankle go score and internal validations	Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests	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
group of the external validation stage of the composite score	Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests	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)

Primary Outcome Measures

Name	Time	Method
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	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)

Secondary Outcome Measures

Name	Time	Method
Reproductibility of the composite score	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.
The composite score's sensibility to change (ability of the composite score to measure patients' progress)	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
Discriminating ability of the composite score	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

Trial Locations

Locations (1)

Santé Atlantique; 🇫🇷 Nantes, France