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NCT Number: NCT05331365

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

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

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Key information

Conditions

Ankle Sprains Ankle Injuries Leg Injuries Ligament Sprain Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santé Atlantique

Nantes, 44800, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with chronic ankle instability, operated or not, contralateral
  • Patients under legal protection

Treatment and study plan

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

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2022
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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