Tourniquet vs. Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction

Recruiting now · Not applicable

Conditions studied: Anterior Cruciate Ligament Reconstruction

In brief

This is a prospective randomized study comparing tourniquet use versus a dual-flow arthroscopy sheath in Anterior Cruciate Ligament (ACL) reconstruction surgery. The ACL is largely responsible for knee stability and contributes to central pivot with the posterior cruciate ligament. ACL rupture is associated with a violent twisting motion of the knee, which is usually irreparable without surgical intervention. ACL reconstruction via arthroscopy is the gold standard treatment for young, active patients with knee instability. Reconstruction is commonly performed using a thigh tourniquet to improve intraoperative visibility, reduce bleeding, and shorten procedure time. However, numerous studies associate tourniquet use with an increased risk of postoperative complications such as increased pain, muscle injury, postoperative bleeding, and deep vein thrombosis. Therefore, it seems relevant to conduct further investigations into the benefits of new methods to replace tourniquet. In this context, the dual-flow arthroscopy sheath could improve postoperative recovery after ACL reconstruction and could limit the risk of complications, thus improving ambulatory care for patients. This study propose to compare two groups of patients undergoing ACL reconstruction: those operated on with a tourniquet versus those operated on using the dual-flow arthroscopy sheath.

Key facts

Study ID

NCT06819696

Run by

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

People needed

128

Starts

2025-05-12

Expected to finish

2028-04-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary ACL reconstruction
• Age 18 years or older
• Provided informed consent prior to study participation
• Affiliated to or beneficiary of a social security regimen

You may not qualify if…

• Multi-ligamentous surgery
• Revision ACL surgery
• Presence of a meniscal and/or chondral lesion not allowing immediate weight-bearing postoperatively
• Bleeding disorder
• Pregnant, parturient or breastfeeding women
• Patient under legal guardianship
• Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the objectives of the study objectives

Where it is running

• Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer — Toulon, Var, France (enrolling)
• Centre Hospitalier de Hyères — Hyères, Var, France (enrolling)
• CHU de Reims — Reims, Marne, France

Full record on ClinicalTrials.gov

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