The Implications of Tourniquet Use on Early Quadriceps Function in Anterior Cruciate Ligament Reconstructions: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Limb symmetry index (LSI)
研究概览
简要总结
The purpose of this study is to assess the intra-operative and post-operative effects of tourniquet use during ACL reconstruction. We hypothesize that:
- Limited tourniquet use will not significantly impact arthroscopic visualization nor the time it takes to complete an ACL reconstruction.
- Limited tourniquet use will lead to significantly less patient pain intra-operatively and in the immediate peri-operative period.
- Patients who undergo an ACL reconstruction with limited tourniquet use will have earlier return of quadriceps functions as compared to those undergoing reconstruction with the use of a tourniquet.
详细描述
Type of Study Double-blinded randomized controlled clinical trial
Group 1 (Control): Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case.
Group 2 (Treatment/Intervention, if applicable): Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Treating physicians and subjects will be blinded to treatment group.
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
- •Patients undergoing an arthroscopic assisted ACLR using a bone-tendon-bone patellar tendon autograft.
- •18 years or older
- •English speaking
排除标准
- •Concomitant procedures (e.g., osteotomy or other ligamentous reconstructions) other than chondroplasty, partial meniscectomy or meniscal repair
- •Medical contraindications to epinephrine or TXA use.
- •Hemophilia or other predisposition for bleeding
- •Does not follow study protocol in regard to regional anesthesia, TXA, epinephrine use in the arthroscopy fluid and post-operative rehabilitation.
- •Participation in physical therapy at any facility other than the OrthoCarolina Randolph, Matthews or South Park locations
研究组 & 干预措施
Control
Patients undergoing patellar bone-tendon-bone autograft ACL reconstruction with a tourniquet used for the duration of the case.
Treatment/Intervention
Patients undergoing ACL reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.
干预措施: Patients undergoing ACL reconstruction with or without a tourniquet (Procedure)
结局指标
主要结局
Limb symmetry index (LSI)
时间窗: 6 months
Limb symmetry index (LSI) of the peak torque of the quadriceps
次要结局
- IKDC and the Marx Activity Rating Scale scores(1 year)
- Arthroscopic visibility(during surgery)
- Limb symmetry index (LSI)(3 months)
- Post-operative pain in PACU(during surgery)
- Operative time(during surgery)
- Intra-operative opioid requirements(during surgery)
- Quadriceps circumference(preoperative, 2 weeks, 6 weeks, 3 months and 6 months)
- Number of days post-operatively until the patient can complete a straight leg raise with no extensor lag at physical therapy.(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- PACU opioid requirements(during surgery)
- Number of days post-operatively until the patient can actively hyper-extend their knee at physical therapy.(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months)
- LSI of peak strength and rate of torque development of the quadriceps(6 months)