About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary ACL reconstruction
Age 18 years or older
Provided informed consent prior to study participation
Affiliated to or beneficiary of a social security regimen
Disqualifiers
Multi-ligamentous surgery
Revision ACL surgery
Presence of a meniscal and/or chondral lesion not allowing immediate weight-bearing postoperatively
Bleeding disorder
Trial design
Parallel
Treatments tested in this trial
ACL reconstruction with a dual-flow arthroscopy sheath
Procedure/SurgeryACL reconstruction will be performed by the surgeon without a tourniquet but using a dual-flow arthroscopy sheath.
ACL reconstruction with a thigh tourniquet
Procedure/SurgeryACL reconstruction will be performed by the surgeon using a thight tourniquet
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Arthrogenic Muscle Inhibition (AMI) classification
This classification is used to assess quadriceps contraction.
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.
Sponsors and contacts
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