NCT06819696

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

A Prospective, Randomized Controlled Study Comparing Tourniquet Use Versus a Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction Surgery.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Initial assessments will be conducted preoperatively. The follow-up examination will take place during the first 7 days following surgery and then at 21 days (D21), 45 days (D45), and 5 months postoperatively.

Conditions

• Anterior Cruciate Ligament Reconstruction

Interventions

Type	Name	Description
PROCEDURE	ACL reconstruction with a dual-flow arthroscopy sheath	ACL reconstruction will be performed by the surgeon without a tourniquet but using a dual-flow arthroscopy sheath.
PROCEDURE	ACL reconstruction with a thigh tourniquet	ACL reconstruction will be performed by the surgeon using a thight tourniquet

Timeline

• Start date: 2025-05-12
• Primary completion: 2026-10-01
• Completion: 2027-03-01
• First posted: 2025-02-11
• Last updated: 2026-04-13

Locations

2 sites across 1 country: France