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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
ACL reconstruction will be performed by the surgeon without a tourniquet but using a dual-flow arthroscopy sheath.
ACL reconstruction will be performed by the surgeon using a thight tourniquet
Centre Hospitalier de Hyères
Hyères, Var, France
RECRUITINGCentre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Toulon, Var, France
RECRUITINGPostoperative 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.
Time frame: 4 days after surgery
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.
Time frame: 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.
Time frame: Up to 4 days after surgery
Arthrogenic Muscle Inhibition (AMI) classification
This classification is used to assess quadriceps contraction.
Time frame: 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.
Time frame: 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.
Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery
Knee mobility
Knee mobility will be assessed using a goniometer.
Time frame: Preoperative, Day 21, Day 45 and Month 5 after surgery
Total surgical time
Assessed in minutes
Time frame: Day 0
Arthroscopic time
Assessed in minutes
Time frame: During procedure
Intraoperative visibility
Intraoperative visibility will be assessed by the surgeon using a 4-point scale (excellent, good, fair, poor).
Time frame: During procedure
Thigh, knee and calf diameters in cm
Diameters will be evaluated 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
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.
Time frame: Up to 5 months
Muscle strength
Muscle strength will be assessed in both limbs using isokinetic testing
Time frame: Preoperative and 5 months
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