Anterior Cruciate Ligament RuptureNCT04668677
Return to Work and Functional Results of French Soldiers After Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Rupture, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
The return to work in the military population after surgical reconstruction of the anterior cruciate ligament (ACL) has been poorly investigated within the French armed forces. Only American studies are available and show that this surgery has a significant impact on the operational capacity of soldiers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- On-line questionnaire
- How many people
- 222 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2020to 6 Jan 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be composed of military personnel who underwent first-line ACL reconstruction surgery in a military hospital (military training hospital Bégin or military training hospital Percy) between January 2014 and May 2019.
Who may be able to join
- Military personnel who underwent first-line ACL reconstruction surgery between January 2014 and May 2019
Who cannot join
- People who have had ACL reconstruction surgery after initial failure
- People with a multiligamentous knee condition
Trial locations and contacts
1 site in 1 country.
About this study
The return to work in the military population after surgical reconstruction of the anterior cruciate ligament (ACL) has been poorly investigated within the French armed forces. Only American studies are available and show that this surgery has a significant impact on the operational capacity of soldiers.
ACL rupture is extremely frequent in active populations. This pathology has already been extensively explored in at-risk populations, particularly in sports. Most studies show that the resumption of sport is greatly affected by this pathology.
Furthermore, an over-risk (10 times greater incidence of ACL rupture) in the military has been demonstrated.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- On-line questionnaire
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-line questionnaireOther
On-line questionnaire about working life, medical care, functional recovery, quality of life and psychological state.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who regained their professional competence one year after anterior cruciate ligament (ACL) reconstruction surgery.
Measured: 1 year after anterior cruciate ligament (ACL) reconstruction surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start10 Dec 2020
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
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
- NCT04668677
- Sponsor's protocol ID
- 2020PPRC10
- Other IDs
- 2020-A02234-35
- Status last verified
- Mar 2021
- First submitted
- 9 Dec 2020
- Last updated
- 9 Mar 2021
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work and Functional Results of French Soldiers After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04668677
- Acronym / sponsor ID
- 2020PPRC10
- Conditions
- Anterior Cruciate Ligament Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 16 Dec 2020 (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.
The return to work in the military population after surgical reconstruction of the anterior cruciate ligament (ACL) has been poorly investigated within the French armed forces. Only American studies are available and show that this surgery has a significant impact on the operational capacity of soldiers.
ACL rupture is extremely frequent in active populations. This pathology has already been extensively explored in at-risk populations, particularly in sports. Most studies show that the resumption of sport is greatly affected by this pathology.
Furthermore, an over-risk (10 times greater incidence of ACL rupture) in the military has been demonstrated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of military personnel who underwent first-line ACL reconstruction surgery in a military hospital (military training hospital Bégin or military training hospital Percy) between January 2014 and May 2019.
Key inclusion criteria (1 listed)
- Military personnel who underwent first-line ACL reconstruction surgery between January 2014 and May 2019
Key exclusion criteria (2 listed)
- People who have had ACL reconstruction surgery after initial failure
- People with a multiligamentous knee condition
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 questionnaireOn-line questionnaire about working life, medical care, functional recovery, quality of life and psychological state. | Other | – |
Primary outcome
Percentage of participants who regained their professional competence one year after anterior cruciate ligament (ACL) reconstruction surgery.
Time frame: 1 year after anterior cruciate ligament (ACL) reconstruction surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anterior Cruciate Ligament Rupture, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 9 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who regained their professional competence one year after anterior cruciate ligament (ACL) reconstruction surgery. (time frame: 1 year after anterior cruciate ligament (ACL) reconstruction surgery.). 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 9 Mar 2021.