NCT06178484

Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 144 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Isolated ruptures of the anterior cruciate ligament (ACL) can be proximal, distal or occur in the middle of the ACL. 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 the risk of progression to a knee functionally unstable less marked. In athletes, the risk of a new sprain must be explained and the patient will choose a functional treatment or a surgical treatment. Few studies exist in the literature on the superiority of surgical treatment compared to functional treatment. In this context, this study is based on the hypothesis that patients undergoing ACL surgical repair have better functional scores and more intense sport activity than patients with functional treatment.

Detailed description

Isolated ruptures of the anterior cruciate ligament (ACL) are ligament injuries which lead to the most surgical interventions on the capsuloligamentous system of the knee. These ruptures can be proximal, distal or occur in the middle of the ACL. Treatment of patients with proximal lesions should be graded and should take into account patient's symptoms (feeling of instability), physical examination data, amount of residual ligament, sport practice, practice level, time interval since the initial trauma, work requirements… Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and the risk of progression to a knee functionally unstable (positive pivot shift) less marked. In athletes, the risk of a new sprain must be explained and the patient will choose a functional treatment or a 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 rupture complete when resuming sporting activities. If instability is revealed, it is then necessary 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 ACL proximal tear, the patient may be offered surgical repair of the ACL. There are many studies on the results of ACL ligamentoplasties but literature is poor on the outcomes of modern ACL repairs. Surgical repair of the proximal rupture of ACL has experienced renewed interest in recent years thanks to the appearance of new fixing systems. Used in the 70s and 80s, this technique was gradually little abandoned in the mid-1980s following disappointing results in favor autograft reconstruction techniques. Few studies exist in the literature on the superiority of surgical treatment compared to functional treatment. In this context, this study is based on the hypothesis that patients undergoing ACL surgical repair have better functional scores and more intense sport activity than patients with functional treatment.

Conditions

• ACL - Anterior Cruciate Ligament Deficiency

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-12-21
• Last updated: 2023-12-29

Locations

1 site across 1 country: France