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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: Procedure: ACL reconstruction with a dual-flow arthroscopy sheath; Procedure: ACL reconstruction with a thigh tourniquet

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magali CESANA; Phone Number: +33 04 83 77 20 60; Email: magali.cesana@ch-toulon.fr
• Study Contact Backup: Name: Steven LAUJAC; Phone Number: +33 04 94 14 60 67; Email: Steven.Laujac@ch-toulon.fr

Study Locations

• France
  • Var
    • Hyères, Var, France, 83400
      • Recruiting
      • Centre Hospitalier de Hyères
      • Contact: Cédric SIEDLECKI, MD; Phone Number: +33 04 94 14 50 00; Email: cedric.siedlecki@ch-toulon.fr
    • Toulon, Var, France, 83100
      • Recruiting
      • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
      • Contact: Jean-Charles ESCUDIER, MD; Phone Number: +33 04 94 14 50 00; Email: jean-charles.escudier@ch-toulon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual-flow arthroscopy sheath; Patients will undergo ACL reconstruction using a dual-flow arthroscopy sheath.	Procedure: 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.
Active Comparator: Thigh tourniquet; Patients will undergo ACL reconstruction using a thigh tourniquet.	Procedure: ACL reconstruction with a thigh tourniquet; ACL reconstruction will be performed by the surgeon using a thight tourniquet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity according to a Numeric Rating Scale (NRS)	Pain intensity will be assessed using a Numeric Rating Scale (NRS) on the day of surgery (preoperatively and at 4, 12, and 16 hours postoperatively) and on days 1, 2, and 3 following surgery (at 8 AM, 12 PM, and 8 PM). The minimum value of the scale, corresponding to no pain at all, is 0 and the maximum value is 10.	Up to 3 days after surgery
Total antalgic consumption	Total antalgic consumption will be assessed in number of doses per type of drug, from surgery up to 4 days after surgery.	Up to 4 days after surgery
Arthrogenic Muscle Inhibition (AMI) classification	This classification is used to assess quadriceps contraction.	Preoperative, on Day 0 before and after surgery and then on Day 21 and Day 45 after surgery.
Lysholm knee scoring scale	The Lysholm Knee Score is a standardized questionnaire used to assess knee function after surgery. The total score obtained ranges from 0 to 100. The higher the score, the better the knee's function.	Preoperative, Day 21, Day 45 and Month 5 after surgery
Knee Blessure and Osteoarthritis Outcomescore (KOOS)	The KOOS is a self-administered questionnaire that evaluates multiple aspects of knee health, including pain, symptoms, daily living activities, sports and recreation function, and quality of life. Each subscale is rated from 0 to 100, where 0 represents extreme problems and 100 represents no problem.	Preoperative, Day 21, Day 45 and Month 5 after surgery
Knee mobility	Knee mobility will be assessed using a goniometer.	Preoperative, Day 21, Day 45 and Month 5 after surgery
Total surgical time	Assessed in minutes	Day 0
Arthroscopic time	Assessed in minutes	During procedure
Intraoperative visibility	Intraoperative visibility will be assessed by the surgeon using a 4-point scale (excellent, good, fair, poor).	During procedure
Thigh, knee and calf diameters in cm	Diameters will be evaluated in cm.	Preoperative and Day 21
CPK blood level		Preoperative and Day 1
Hemoglobin level		Preoperative, Day 1 and Day 7
Presence of complications	The number and type of complications will be recorded, including hematomas, knee stiffness, deep vein thrombosis, complex regional pain syndrome, deep infection, superficial infection, and recurrent anterior cruciate ligament graft rupture.	Up to 5 months
Muscle strength	Muscle strength will be assessed in both limbs using isokinetic testing	Preoperative and 5 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Investigators: Study Director: Cédric SIEDLECKI, MD, Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer and Centre Hospitalier de Hyères

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pain; Anterior Cruciate Ligament; Surgery; Tourniquet; Arthroscopy; Dual-flow arthroscopy sheath
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 2024-CHITS-007; 2024-A01117-40 (Other Identifier: ID-RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No