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Recruiting NCT06819696

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

No phase Interventional Anterior Cruciate Ligament Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACL reconstruction with a dual-flow arthroscopy sheath, ACL reconstruction with a thigh tourniquet.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Reconstruction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.
  • Procedure ACL reconstruction with a thigh tourniquet
    ACL reconstruction will be performed by the surgeon using a thight tourniquet

Primary outcome measures

  • Postoperative pain intensity according to a Numeric Rating Scale (NRS) [Time frame: 4 days after surgery]
Secondary outcome measures (12)
  • Pain intensity according to a Numeric Rating Scale (NRS) [Time frame: Up to 3 days after surgery]
  • Total antalgic consumption [Time frame: Up to 4 days after surgery]
  • 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.]
  • Lysholm knee scoring scale [Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery]
  • Knee Blessure and Osteoarthritis Outcomescore (KOOS) [Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery]
  • Knee mobility [Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery]
  • Total surgical time [Time frame: Day 0]
  • Arthroscopic time [Time frame: During procedure]
  • Intraoperative visibility [Time frame: During procedure]
  • Thigh, knee and calf diameters in cm [Time frame: Preoperative and Day 21]
  • CPK blood level [Time frame: Preoperative and Day 1]
  • Hemoglobin level [Time frame: Preoperative, Day 1 and Day 7]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 3 centers
  • CHU de Reims — Reims
  • Centre Hospitalier de Hyères — Hyères
  • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer — Toulon

Identifiers

NCT: NCT06819696 · 2024-CHITS-007 · 2024-A01117-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗