Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06819696

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

Led by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Updated on 2026-04-13

128

Participants Needed

2

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary ACL reconstruction
  • Age 18 years or older
  • Provided informed consent prior to study participation
  • Affiliated to or beneficiary of a social security regimen
Not Eligible

You will not qualify if you...

  • 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

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Trial Site Locations

Total: 2 locations

1

Centre Hospitalier de Hyères

Hyères, Var, France, 83400

Actively Recruiting

2

Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Toulon, Var, France, 83100

Actively Recruiting

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Research Team

M

Magali CESANA

CONTACT

S

Steven LAUJAC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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