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

Intermunicipal Hospital Center Toulon

Status: Enrolling

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Procedure: ACL reconstruction with a thigh tourniquet; Procedure: ACL reconstruction with a dual-flow arthroscopy sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT06819696

2024-A01117-40 (Other Identifier)

2024-CHITS-007

Details and patient eligibility

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.

Full description

Initial assessments will be conducted preoperatively. The follow-up examination will take place during the first 7 days following surgery and then at 21 days (D21), 45 days (D45), and 5 months postoperatively.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Dual-flow arthroscopy sheath

Experimental group

Description:

Patients will undergo ACL reconstruction using a dual-flow arthroscopy sheath.

Treatment:

Procedure: ACL reconstruction with a dual-flow arthroscopy sheath

Thigh tourniquet

Active Comparator group

Description:

Patients will undergo ACL reconstruction using a thigh tourniquet.

Treatment:

Procedure: ACL reconstruction with a thigh tourniquet