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NCT Number: NCT06178497

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé La Louvière

Lille, Choisir Une Région, 59800, France

Location status: Recruiting

Location contact

Romain LETARTRE

CONTACT

[email protected]

+33320557000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ACL rupture relapse rate

    Time frame: 1 day

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

Study contacts

Contact information is provided by the study sponsor or research team.

Romain LETARTRE, MD

CONTACT

[email protected]

+ 33 3 20 55 70 00

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: RUPTUPROX

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2023
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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