Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06819696

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anterior Cruciate Ligament Reconstruction Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Reims, Reims, Marne, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

ACL reconstruction with a thigh tourniquet

Procedure

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

Primary outcomes

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

    Time frame: 4 days after surgery

    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.

Secondary outcomes

  1. Pain intensity according to a Numeric Rating Scale (NRS)

    Time frame: Up to 3 days after surgery

    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.

  2. Total antalgic consumption

    Time frame: Up to 4 days after surgery

    Total antalgic consumption will be assessed in number of doses per type of drug, from surgery up to 4 days after surgery.

  3. Arthrogenic Muscle Inhibition (AMI) classification

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

    This classification is used to assess quadriceps contraction.

  4. Lysholm knee scoring scale

    Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery

    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.

  5. Knee Blessure and Osteoarthritis Outcomescore (KOOS)

    Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery

    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.

  6. Knee mobility

    Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery

    Knee mobility will be assessed using a goniometer.

  7. Total surgical time

    Time frame: Day 0

    Assessed in minutes

  8. Arthroscopic time

    Time frame: During procedure

    Assessed in minutes

  9. Intraoperative visibility

    Time frame: During procedure

    Intraoperative visibility will be assessed by the surgeon using a 4-point scale (excellent, good, fair, poor).

  10. Thigh, knee and calf diameters in cm

    Time frame: Preoperative and Day 21

    Diameters will be evaluated in cm.

  11. CPK blood level

    Time frame: Preoperative and Day 1

  12. Hemoglobin level

    Time frame: Preoperative, Day 1 and Day 7

  13. Presence of complications

    Time frame: Up to 5 months

    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.

  14. Muscle strength

    Time frame: Preoperative and 5 months

    Muscle strength will be assessed in both limbs using isokinetic testing

Study contacts

Contact information is provided by the study sponsor or research team.

Magali CESANA

CONTACT

[email protected]

04 83 77 20 60 ext. +33

Steven LAUJAC

CONTACT

[email protected]

04 94 14 60 67 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Official study title

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

Acronym: RELICA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 11, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.