Ankle SprainsLITCHEENCT05562700
Assessment of Return to Work and Functional Results of French Military Personnel After Ankle Ligamentoplasty
An observational study of Ankle Sprains, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- On-line questionnaire
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2023to 14 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be composed of military personnel who have undergone primary ankle ligamentoplasty surgery between January 2015 and December 2021.
Who may be able to join
- Military personnel,
- Primary ankle ligamentoplasty surgery between January 2015 and December 2021,
- Sufficient French language reading/writing level (elementary school level).
Who cannot join
- Ankle ligament surgery after a first failure.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital d'Instruction des Armées Percy
Clamart, 92140
Nicolas DE L'ESCALOPIER, MD, 661061900 ext. +33, nicolas.de-l'escalopier@intradef.gouv.fr
About this study
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.
Read more
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).
- Conditions
- Ankle Sprains
- Being tested
- On-line questionnaire
- Keywords
- Ligamentoplasty
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-line questionnaireOther
It is a self-administered questionnaire (20 minutes) with several subparts:
- Socio-demographic questions: age, height, weight, smoking status, etc.
- Care: date of accident, initial treatment, duration of symptoms, complications, return to work, return to sport, recovery of skills, etc.
- Functional results
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who returned to their previous job six months after ankle ligamentoplasty surgery
Measured: Through study completion (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start14 Jan 2023
- Primary completion14 Jan 2024 (estimated)
- Study completion14 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562700
- Sponsor's protocol ID
- 2021PPRC14
- Other IDs
- 2022-A01577-36
- Acronym
- LITCHEE
- Status last verified
- Apr 2023
- First submitted
- 28 Sep 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Return to Work and Functional Results of French Military Personnel After Ankle Ligamentoplasty
- ClinicalTrials.gov ID
- NCT05562700
- Acronym / sponsor ID
- LITCHEE / 2021PPRC14
- Conditions
- Ankle Sprains
- Keywords
- Ligamentoplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 14 Jan 2023 (actual)
- Primary completion
- 14 Jan 2024 (estimated)
- Study completion
- 14 Jan 2024 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of military personnel who have undergone primary ankle ligamentoplasty surgery between January 2015 and December 2021.
Key inclusion criteria (3 listed)
- Military personnel,
- Primary ankle ligamentoplasty surgery between January 2015 and December 2021,
- Sufficient French language reading/writing level (elementary school level).
Key exclusion criteria (1 listed)
- Ankle ligament surgery after a first failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-line questionnaireIt is a self-administered questionnaire (20 minutes) with several subparts: * Socio-demographic questions: age, height, weight, smoking status, etc. * Care: date of accident, initial treatment, duration of symptoms, complications, return to work, return to sport, recovery of skills, etc. * Functional results | Other | – |
Primary outcome
Percentage of participants who returned to their previous job six months after ankle ligamentoplasty surgery
Time frame: Through study completion (12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Sprains, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas DE L'ESCALOPIER, MD (661061900 ext. +33, nicolas.de-l'escalopier@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who returned to their previous job six months after ankle ligamentoplasty surgery (time frame: Through study completion (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.