RecruitingNot ApplicableNCT06819696

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.


Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Enrollment

128 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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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Interventions

PROCEDUREACL 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.

PROCEDUREACL reconstruction with a thigh tourniquet

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


Locations(2)

Centre Hospitalier de Hyères

Hyères, Var, France

Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Toulon, Var, France

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NCT06819696


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