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

Elsan

Status: Completed

Conditions: Ankle Sprains; Ligament Sprain

Treatments: Other: Construction and evaluation of a composite score evaluating post ankle surgery residual instability by completing questionnaires and undergoing physical tests

Study type: Interventional

Funder types: Other

Identifiers

NCT05331365

Ankle Go study

2021-A03239-32 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 3 patient groups

Group of the construction of the composite Ankle go score and internal validations

Experimental group

Description:

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

Treatment:

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

group of the external validation stage of the composite score

Experimental group

Description:

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)

Treatment:

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

Group allowing the assessment of the score's ability to discriminate

No Intervention group

Description:

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