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Clinical Trials in France / NCT06819696
Recruiting Not applicable

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

NCT06819696 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Phase
Not applicable
Started
2025-05-12
Last updated
2026-07-07

Condition(s) studied

Anterior Cruciate Ligament Reconstruction

Investigational drug(s) / intervention(s)

ACL reconstruction with a dual-flow arthroscopy sheathACL reconstruction with a thigh tourniquet

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.

ACL reconstruction with a thigh tourniquet: ACL reconstruction will be performed by the surgeon using a thight tourniquet

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Primary ACL reconstruction * Age 18 years or older * Provided informed consent prior to study participation * Affiliated to or beneficiary of a social security regimen Exclusion Criteria: * 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

Primary outcome measure(s)

  • Postoperative pain intensity according to a Numeric Rating Scale (NRS) — 4 days after surgery
    Pain intensity will be assessed using a Numeric Rating Scale (NRS) at 8 AM, 12 PM, and 8 PM on postoperative day 4. The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10.

Trial sites (3)

FacilityCityRegionStatus
CHU de Reims Reims Marne Not Yet Recruiting
Centre Hospitalier de Hyères Hyères Var Recruiting
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer Toulon Var Recruiting

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Other trials for the same condition

Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06819696 on ClinicalTrials.gov ↗ ← All trials in France