Clinical trial NCT06819696: Tourniquet vs. Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction
Official title: A Prospective, Randomized Controlled Study Comparing Tourniquet Use Versus a Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction Surgery.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Anterior Cruciate Ligament
Arthroscopy
Dual-flow arthroscopy sheath
Tourniquet
pain
Surgery
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Postoperative pain intensity according to a Numeric Rating Scale (NRS)
timeFrame: 4 days after surgery
Secondary outcomes:
measure: Pain intensity according to a Numeric Rating Scale (NRS)
timeFrame: Up to 3 days after surgery
measure: Total antalgic consumption
timeFrame: Up to 4 days after surgery
measure: Arthrogenic Muscle Inhibition (AMI) classification
timeFrame: Preoperative, on Day 0 before and after surgery and then on Day 21 and Day 45 after surgery.
measure: Lysholm knee scoring scale
timeFrame: Preoperative, Day 21, Day 45 and Month 5 after surgery
measure: Knee Blessure and Osteoarthritis Outcomescore (KOOS)
timeFrame: Preoperative, Day 21, Day 45 and Month 5 after surgery
measure: Knee mobility
timeFrame: Preoperative, Day 21, Day 45 and Month 5 after surgery
measure: Total surgical time
timeFrame: Day 0
measure: Arthroscopic time
timeFrame: During procedure
measure: Intraoperative visibility
timeFrame: During procedure
measure: Thigh, knee and calf diameters in cm
timeFrame: Preoperative and Day 21
measure: CPK blood level
timeFrame: Preoperative and Day 1
measure: Hemoglobin level
timeFrame: Preoperative, Day 1 and Day 7
measure: Presence of complications
timeFrame: Up to 5 months
measure: Muscle strength
timeFrame: Preoperative and 5 months
Other outcomes:
Locations:
city: Hyères
country: France
facility: Centre Hospitalier de Hyères
state: Var
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer and Centre Hospitalier de Hyères
name: Cédric SIEDLECKI, MD
role: STUDY_DIRECTOR
References: