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

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.

Study Overview

• Status: Recruiting
• Conditions: ACL - Anterior Cruciate Ligament Deficiency

Detailed Description

Isolated ruptures of ACL (anterior cruciate ligament) are ligament injuries which lead to the most surgical interventions on the capsuloligamentous system of the knee. These ruptures can be proximal, central or distal.

Treatment of patients with proximal lesions should be graded and should take into account the patient's symptoms (feeling of instability), physical examination data, amount of residual ligament, sport practice, practice level, interval time since the initial trauma, work requirements… Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and tprogression 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.

Functional treatment is variable, combining the use of splints, rehabilitation, muscle strengthening. The healing time is three months. Wearing a splint has not proven its effectiveness in preventing progression to complete rupture when resuming sport activities. If instability is revealed, it is then necessary to move towards ACL reconstruction 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 also be offered surgical repair of the ACL. There are numerous studies on ACL ligamentoplasties results but literature is poor on modern ACL repairs outcomes. Surgical repair of proximal rupture of ACL has experienced renewed interest in recent years thanks to the appearance of new fixing systems. Used in the 1980s, this technique was gradually abandoned in the mid-1980s following disappointing results for the benefit of autograft reconstruction techniques.

Few studies exist in the literature on long-term ACL repair surgery follow-up. In this context, this study aims to describe the relapse rate at 5 years of patients operated for a proximal ACL tear.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Romain LETARTRE, MD; Phone Number: + 33 3 20 55 70 00; Email: romainletartre@yahoo.fr

Study Locations

• France
  • Choisir Une Région
    • Lille, Choisir Une Région, France, 59800
      • Recruiting
      • Hôpital Privé La Louvière
      • Contact: Romain LETARTRE; Phone Number: +33320557000; Email: romainletartre@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACL rupture relapse rate	ACL rupture relapse will be assessed on MRI 5 years after ACL surgery	1 day

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Romain LETARTRE, MD, Hôpital Privé La Louvière

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: RGDS-2023-06-043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No