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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Primary ACL reconstruction

• Age 18 years or older

• Provided informed consent prior to study participation

• Affiliated to or beneficiary of a social security regimen

Locations
Other Locations
France
Centre Hospitalier de Hyères
RECRUITING
Hyères
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
RECRUITING
Toulon
Contact Information
Primary
Magali CESANA
magali.cesana@ch-toulon.fr
04 83 77 20 60
Backup
Steven LAUJAC
Steven.Laujac@ch-toulon.fr
04 94 14 60 67
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2027-03
Participants
Target number of participants: 128
Treatments
Experimental: Dual-flow arthroscopy sheath
Patients will undergo ACL reconstruction using a dual-flow arthroscopy sheath.
Active_comparator: Thigh tourniquet
Patients will undergo ACL reconstruction using a thigh tourniquet.
Sponsors
Leads: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

This content was sourced from clinicaltrials.gov

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