A Prospective, Randomized Controlled Study Comparing Tourniquet Use Versus a Dual-flow Arthroscopy Sheath in Anterior Cruciate Ligament (ACL) Reconstruction Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 5
- 主要终点
- Postoperative pain intensity according to a Numeric Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patient will be masked to the surgical procedure and will be unblinded upon completion of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary ACL reconstruction
- •Age 18 years or older
- •Provided informed consent prior to study participation
- •Affiliated to or beneficiary of a social security regimen
排除标准
- •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
研究组 & 干预措施
Dual-flow arthroscopy sheath
Patients will undergo ACL reconstruction using a dual-flow arthroscopy sheath.
干预措施: ACL reconstruction with a dual-flow arthroscopy sheath (Procedure)
Thigh tourniquet
Patients will undergo ACL reconstruction using a thigh tourniquet.
干预措施: ACL reconstruction with a thigh tourniquet (Procedure)
结局指标
主要结局
Postoperative pain intensity according to a Numeric Rating Scale (NRS)
时间窗: 4 days after surgery
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.
次要结局
- Muscle strength(Preoperative and 5 months)
- Total surgical time(Day 0)
- Pain intensity according to a Numeric Rating Scale (NRS)(Up to 3 days after surgery)
- Total antalgic consumption(Up to 4 days after surgery)
- Arthrogenic Muscle Inhibition (AMI) classification(Preoperative, on Day 0 before and after surgery and then on Day 21 and Day 45 after surgery.)
- Intraoperative visibility(During procedure)
- Knee Blessure and Osteoarthritis Outcomescore (KOOS)(Preoperative, Day 21, Day 45 and Month 5 after surgery)
- Thigh, knee and calf diameters in cm(Preoperative and Day 21)
- Knee mobility(Preoperative, Day 21, Day 45 and Month 5 after surgery)
- Arthroscopic time(During procedure)
- Hemoglobin level(Preoperative, Day 1 and Day 7)
- Presence of complications(Up to 5 months)
- Lysholm knee scoring scale(Preoperative, Day 21, Day 45 and Month 5 after surgery)
- CPK blood level(Preoperative and Day 1)