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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-12

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anterior Cruciate Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The patient will be masked to the surgical procedure and will be unblinded upon completion of the study.

Study Groups

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Dual-flow arthroscopy sheath

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

Group Type EXPERIMENTAL

ACL reconstruction with a dual-flow arthroscopy sheath

Intervention Type PROCEDURE

ACL reconstruction will be performed by the surgeon without a tourniquet but using a dual-flow arthroscopy sheath.

Thigh tourniquet

Patients will undergo ACL reconstruction using a thigh tourniquet.

Group Type ACTIVE_COMPARATOR

ACL reconstruction with a thigh tourniquet

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

ACL reconstruction with a thigh tourniquet

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No