Ligament RuptureINFO-LCANCT05585528
Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament
A study testing Functional or surgical management in 1st intention in people with Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of the study is to evaluate the proportion of patients after rupture of the anterior cruciate ligament (ACL) of the knee, who will have functional or surgical management (PEC) in 1st intention, after having received appropriate information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ligament Rupture
- What is being tested?
- Functional or surgical management in 1st intention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2022to 29 Mar 2026
- Phase
- Interventional
- 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
Who may be able to join
- Rupture, partial or complete, of the anterior cruciate ligament less than 3 months old (confirmed by magnetic resonance imaging);
- Patient with no contraindication to surgery or functional management, according to the medical team;
- Patient able to understand the information related to the study, to read the information leaflet and having consented to participate in the study
- Patient benefiting from a social security scheme;
Who cannot join
- Grade 3 associated ligament injury on the fibular collateral ligament and/or the tibial collateral ligament;
- Symptomatic meniscal lesion;
- Practice of sport in national or international competition ;
- Recurrence of rupture of the same anterior cruciate ligament;
- Patient with a neurological (motor and/or sensory), vestibular or rheumatic pathology;
- Pregnant woman ;
- Protected adult patient (under guardianship, or under a regime of deprivation of liberty).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament : INFO-LCA
The purpose of the study is to evaluate the proportion of patients after rupture of the anterior cruciate ligament (ACL) of the knee, who will have functional or surgical management (PEC) in 1st intention, after having received appropriate information.
Read the detailed description
As part of this study, patients will be followed for 1 year with regular functional and quality of life assessments (45 days after inclusion, 3, 6, 9 and 12 months after the start of surgical or non-surgical management). Patients who, during follow-up, will have been redirected towards surgery by the doctor (in the event of functional instability) or who will have chosen to finally move towards surgical PEC, will also be followed.
- Conditions
- Ligament Rupture
- Being tested
- Functional or surgical management in 1st intention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional or surgical management in 1st intentionProcedure or surgery
Proportion of patients after rupture of the anterior cruciate ligament of the knee, who will have functional or surgical management in 1st intention
| Study group | Role | What they receive |
|---|---|---|
| Type of management, surgical or functional, after rupture of the anterior cruciate ligament | Other | Patients will choose the type of management, surgical or functional, after rupture of the anterior cruciate ligament. Receives: Procedure: Functional or surgical management in 1st intention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients operated at 45 days
Rate of patients in the total population who underwent surgery 45 days after anterior cruciate ligament rupture
Measured: 45 days
Secondary outcomes (1)
Proportion of patients who persist in the choice of non-surgical
To assess the proportion of patients who persist in the choice of non-surgical management at 3, 6, 9 and 12 months (in patients who had initial non-surgical management).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start20 Dec 2022
- Primary completion29 Mar 2026
- Study completion29 Mar 2026
Why it stopped: The sponsor, in consultation with the principal investigator, decided to stop the study prematurely (given the small number of eligible patients).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligament RuptureStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, longitudinal, open, non-comparative (single arm), monocentric study.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585528
- Sponsor's protocol ID
- 2022-A00931-42
- Acronym
- INFO-LCA
- Status last verified
- Mar 2026
- First submitted
- 14 Oct 2022
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament : INFO-LCA
- ClinicalTrials.gov ID
- NCT05585528
- Acronym / sponsor ID
- INFO-LCA / 2022-A00931-42
- Conditions
- Ligament Rupture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor, in consultation with the principal investigator, decided to stop the study prematurely (given the small number of eligible patients).
- Enrolment
- 106 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 29 Mar 2026 (actual)
- Study completion
- 29 Mar 2026 (actual)
- First posted
- 18 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.
The purpose of the study is to evaluate the proportion of patients after rupture of the anterior cruciate ligament (ACL) of the knee, who will have functional or surgical management (PEC) in 1st intention, after having received appropriate information.
Detailed description
As part of this study, patients will be followed for 1 year with regular functional and quality of life assessments (45 days after inclusion, 3, 6, 9 and 12 months after the start of surgical or non-surgical management). Patients who, during follow-up, will have been redirected towards surgery by the doctor (in the event of functional instability) or who will have chosen to finally move towards surgical PEC, will also be followed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, longitudinal, open, non-comparative (single arm), monocentric study.
| Arm | Type | Receives |
|---|---|---|
| Type of management, surgical or functional, after rupture of the anterior cruciate ligament | Other | Procedure: Functional or surgical management in 1st intentionPatients will choose the type of management, surgical or functional, after rupture of the anterior cruciate ligament. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rupture, partial or complete, of the anterior cruciate ligament less than 3 months old (confirmed by magnetic resonance imaging);
- Patient with no contraindication to surgery or functional management, according to the medical team;
- Patient able to understand the information related to the study, to read the information leaflet and having consented to participate in the study
- Patient benefiting from a social security scheme;
Key exclusion criteria (7 listed)
- Grade 3 associated ligament injury on the fibular collateral ligament and/or the tibial collateral ligament;
- Symptomatic meniscal lesion;
- Practice of sport in national or international competition ;
- Recurrence of rupture of the same anterior cruciate ligament;
- Patient with a neurological (motor and/or sensory), vestibular or rheumatic pathology;
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 |
|---|---|---|
| Functional or surgical management in 1st intentionProportion of patients after rupture of the anterior cruciate ligament of the knee, who will have functional or surgical management in 1st intention | Procedure or surgery | Type of management, surgical or functional, after rupture of the anterior cruciate ligament |
Primary outcome
Proportion of patients operated at 45 days
Time frame: 45 days
Rate of patients in the total population who underwent surgery 45 days after anterior cruciate ligament rupture
1 secondary outcome
Proportion of patients who persist in the choice of non-surgical
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The sponsor, in consultation with the principal investigator, decided to stop the study prematurely (given the small number of eligible patients).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Functional or surgical management in 1st intention in people with Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Apr 2026. 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 was stopped early (reason given: The sponsor, in consultation with the principal investigator, decided to stop the study prematurely (given the small number of eligible patients).). Results are not available in the source record.
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?
Proportion of patients operated at 45 days (time frame: 45 days). 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 6 Apr 2026.