Assessment of Return to Work and Functional Results of French Military Personnel After Ankle Ligamentoplasty (LITCHEE)

April 27, 2023 updated by: Direction Centrale du Service de Santé des Armées

In the general population, ankle sprains are one of the most common injuries, accounting for approximately 20% of all sports injuries and the most frequent reason for trauma consultation (4 to 7% of admissions to emergency departments in France).

The most frequent complication after an episode of ankle sprain is the development of chronic ankle instability (5 to 40% of the patients). Chronic ankle instability is defined by a history of at least one significant ankle sprain with subsequent perception of an abnormal ankle by the patient, associated with various symptoms including: recurrent sprains, repeated episodes of ankle "slippage", pain, episodes of swelling, difficulty and apprehension when walking on uneven surfaces with a decrease in the functional capacity of the ankle or restriction of activity.

In the military population, ankle sprains account for 18.60% of on-duty injuries, and epidemiologic studies report an incidence of 45.14 to 58.40 sprains per 1,000 person-years.

A 2019 study in a population of French military paratroopers found a prevalence of chronic ankle instability of 43.1% after an ankle sprain.

Chronic ankle instability leads to a loss of operational skills in French soldiers, since it results in a score of 4 for the letter "I" (pelvic girdle and lower limbs) in the SIGYCOP military medical profile. The treatment of chronic ankle instability after failure of rehabilitation consists in ligamentoplasty, conservative or not, in order to restore an external ligament plane and stabilize the ankle. For open techniques, the median time to return to sport after ligamentoplasty is 4.7 months. In the series by Lee et al, which studied more specifically the return to sport in high-level athletes, 83.3% of athletes had returned to competitive sport at 4 months and 100% at 8 months. Management of chronic ankle instability by ligamentoplasty may allow the soldier to regain his operational ability (SIGYCOP score I=2).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Contact

Study Locations

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be composed of military personnel who have undergone primary ankle ligamentoplasty surgery between January 2015 and December 2021.

Description

Inclusion Criteria:

  • Military personnel,
  • Primary ankle ligamentoplasty surgery between January 2015 and December 2021,
  • Sufficient French language reading/writing level (elementary school level).

Exclusion Criteria:

  • Ankle ligament surgery after a first failure.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who returned to their previous job six months after ankle ligamentoplasty surgery
Time Frame: Through study completion (12 months)
Through study completion (12 months)

Collaborators and Investigators

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

Sponsor

Direction Centrale du Service de Santé des Armées

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)

January 14, 2023

Primary Completion (Anticipated)

January 14, 2024

Study Completion (Anticipated)

January 14, 2024

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PPRC14
  • 2022-A01577-36 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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