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

NCT06819696 | Recruiting

• 2 other identifiers: 2024-CHITS-0072024-A01117-40
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Anterior Cruciate Ligament; Arthroscopy; Dual-flow arthroscopy sheath; Tourniquet; pain; Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity according to a Numeric Rating Scale (NRS)

  Pain intensity will be assessed using a Numeric Rating Scale (NRS) at 8 AM, 12 PM, and 8 PM on postoperative day 4. The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10.

  4 days after surgery

Secondary Outcomes (14)

• Pain intensity according to a Numeric Rating Scale (NRS)

  Up to 3 days after surgery

• Total antalgic consumption

  Up to 4 days after surgery

• Arthrogenic Muscle Inhibition (AMI) classification

  Preoperative, on Day 0 before and after surgery and then on Day 21 and Day 45 after surgery.

• Lysholm knee scoring scale

  Preoperative, Day 21, Day 45 and Month 5 after surgery

• Knee Blessure and Osteoarthritis Outcomescore (KOOS)

  Preoperative, Day 21, Day 45 and Month 5 after surgery

Study Arms (2)

Dual-flow arthroscopy sheath

EXPERIMENTAL

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

Procedure: ACL reconstruction with a dual-flow arthroscopy sheath

Thigh tourniquet

ACTIVE COMPARATOR

Patients will undergo ACL reconstruction using a thigh tourniquet.

Procedure: ACL reconstruction with a thigh tourniquet

Interventions

ACL reconstruction with a thigh tourniquet PROCEDURE

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

Thigh tourniquet

ACL reconstruction with a dual-flow arthroscopy sheath PROCEDURE

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

Dual-flow arthroscopy sheath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary ACL reconstruction
• Age 18 years or older
• Provided informed consent prior to study participation
• Affiliated to or beneficiary of a social security regimen

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (2)

Centre Hospitalier de Hyères

Hyères, Var, 83400, France

RECRUITING

Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Toulon, Var, 83100, France

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cédric SIEDLECKI, MD

  Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer and Centre Hospitalier de Hyères

  STUDY DIRECTOR

Central Study Contacts

Magali CESANA

CONTACT

04 83 77 20 60; magali.cesana@ch-toulon.fr

Steven LAUJAC

CONTACT

04 94 14 60 67; Steven.Laujac@ch-toulon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be masked to the surgical procedure and will be unblinded upon completion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)