5 Years' Follow-up Assessment of Surgical Repair for ACL Proximal Rupture

NCT06178497 | Recruiting

• 1 other identifier: RGDS-2023-06-043
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Isolated ruptures of ACL (anterior cruciate ligament) are ligament injuries that can be proximal, central or distal. Treatment of patients with proximal lesions should be graded. Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and progression risk to a functionally unstable knee less marked. In athletes, the risk of a new sprain must be explained and the patient will choose functional treatment or surgical treatment. Surgical treatment generally involves ligamentoplasty at the expense of a knee tendon to replace the ruptured ACL. In the context of proximal ACL rupture, the patient can be offered surgical repair of the ACL. There are numerous studies on ACL ligamentoplasties results but literature is poor on modern ACL repair outcomes. In this context, this study aims to describe the relapse rate at 5 years of patients operated for a proximal ACL tear.

Conditions

ACL - Anterior Cruciate Ligament Deficiency

Outcome Measures

Primary Outcomes (1)

• ACL rupture relapse rate

  ACL rupture relapse will be assessed on MRI 5 years after ACL surgery

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a 5 years MRI follow up after proximal ACL tear repair

You may qualify if:

• Patient, male or female, aged ≥ 18 years
• Patient with no history of knee surgery except meniscal surgery
• Patient with an isolated proximal Sherman 1 or 2 ACL tear
• Patient with a proximal Sherman 1 or 2 ACL tear associated to a meniscal lesion
• Patient with a proximal ACL tear associated with an injury to the MCL or LCL grade 1 or 2 but not grade 3
• Patient whose period is less than 3 months between the date of the accident and the surgery
• Patient who received surgical repair between January 2019 and July 2021

You may not qualify if:

• Patient with contralateral ACL tear
• Patient with ACL tear Sherman 3 or 4
• Patient with a surgical history on the knee concerned, other than meniscal surgery

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé La Louvière

Lille, Choisir Une Région, 59800, France

RECRUITING

Study Officials

• Romain LETARTRE, MD

  Hôpital Privé La Louvière

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain LETARTRE, MD

CONTACT

+ 33 3 20 55 70 00; romainletartre@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 21, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)