Evaluating management options after anterior cruciate ligament rupture
Effect of Informing the Patient on the Type of Management, Surgical or Functional, After Rupture of the Anterior Cruciate Ligament : INFO-LCA
NA · GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT05585528
This study is trying to see how many people with a recent ACL tear choose to manage it with physical therapy or surgery after learning about their options, and how their choices affect their recovery over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche (other) |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05585528 on ClinicalTrials.gov |
What this trial studies
This study aims to assess how many patients with a recent anterior cruciate ligament (ACL) rupture choose functional or surgical management after receiving detailed information about their options. Patients will be monitored for one year, with regular evaluations of their functional status and quality of life at multiple time points. The study will also track those who may require surgery later due to functional instability or personal choice. The goal is to inform better management strategies based on patient preferences and outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals with a recent ACL rupture confirmed by MRI, who are able to understand the study information and consent to participate.
Not a fit: Patients with severe associated ligament injuries, symptomatic meniscal lesions, or those engaged in competitive sports may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help patients make more informed decisions about their treatment options for ACL injuries.
How similar studies have performed: While there have been studies on ACL management, this specific approach focusing on patient-informed decision-making is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Lyon
- Clinique de la Sauvegarde — Lyon, France (RECRUITING)
Study contacts
- Study coordinator: David DEJOUR, MD
- Email: dejour.secretariat@lyon-ortho-clinic.com
- Phone: 4 72 20 00 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ligament Rupture