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

NCT06819696 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Reconstruction

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

    lead OTHER

Principal Investigators

  • Cédric SIEDLECKI, MD · Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer and Centre Hospitalier de Hyères

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2026-10-31
Completion
2027-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06819696 on ClinicalTrials.gov