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Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament

Effect of Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament : INFO-LCA

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05585528
Acronym
INFO-LCA
Enrollment
106
Registered
2022-10-18
Start date
2022-12-20
Completion date
2026-03-29
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ligament Rupture

Brief 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.

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.

Interventions

PROCEDUREFunctional or surgical management in 1st intention

Proportion of patients after rupture of the anterior cruciate ligament of the knee, who will have functional or surgical management in 1st intention

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER
Euraxi Pharma
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Prospective, longitudinal, open, non-comparative (single arm), monocentric study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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;

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients operated at 45 days45 daysRate of patients in the total population who underwent surgery 45 days after anterior cruciate ligament rupture

Secondary

MeasureTime frameDescription
Proportion of patients who persist in the choice of non-surgical12 monthsTo 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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026