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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01117-40 | Other Identifier | ID-RCB number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-flow arthroscopy sheath | Experimental | Patients will undergo ACL reconstruction using a dual-flow arthroscopy sheath. |
|
| Thigh tourniquet | Active Comparator | Patients will undergo ACL reconstruction using a thigh tourniquet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magali CESANA | Contact | 04 83 77 20 60 | +33 | magali.cesana@ch-toulon.fr |
| Steven LAUJAC | Contact | 04 94 14 60 67 | +33 | Steven.Laujac@ch-toulon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Cédric SIEDLECKI, MD | Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer and Centre Hospitalier de Hyères | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Reims | Not yet recruiting | Reims | Marne | 51100 | France |
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The patient will be masked to the surgical procedure and will be unblinded upon completion of the study.
| ACL reconstruction with a thigh tourniquet | Procedure | ACL reconstruction will be performed by the surgeon using a thight tourniquet |
|
| 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. | Up to 4 days after surgery |
| Arthrogenic Muscle Inhibition (AMI) classification | This classification is used to assess quadriceps contraction. | 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. | 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. | Preoperative, Day 21, Day 45 and Month 5 after surgery |
| Knee mobility | Knee mobility will be assessed using a goniometer. | Preoperative, Day 21, Day 45 and Month 5 after surgery |
| Total surgical time | Assessed in minutes | Day 0 |
| Arthroscopic time | Assessed in minutes | During procedure |
| Intraoperative visibility | Intraoperative visibility will be assessed by the surgeon using a 4-point scale (excellent, good, fair, poor). | During procedure |
| Thigh, knee and calf diameters in cm | Diameters will be evaluated in cm. | Preoperative and Day 21 |
| CPK blood level | Preoperative and Day 1 |
| Hemoglobin level | 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. | Up to 5 months |
| Muscle strength | Muscle strength will be assessed in both limbs using isokinetic testing | Preoperative and 5 months |
| Centre Hospitalier de Hyères | Recruiting | Hyères | Var | 83400 | France |
|
| Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer | Recruiting | Toulon | Var | 83100 | France |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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