The Effect of Tourniquet Time and Pressure on Intraoperative and Postoperative Performance, Function, Pain, and Complications in Primary Total Knee Arthroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Postoperative Pain
研究概览
简要总结
This proposed novel randomized control trial (RCT) seeks to address this gap in TKA protocol by gaining a better understanding of the relationship between tourniquet pressure and time, and intraoperative performance and post-operative outcomes. This study does not seek to answer the question of "tourniquet vs no tourniquet", but to seek a tourniquet usage that would maximize the intraoperative benefits for the surgeon and minimize the negative consequences for patient outcomes.
Specific Aim #1: enroll around 146 primary TKA patients.
Specific Aim #2: evaluate different tourniquet cuff pressures (TCP) and tourniquet times in relation to intraoperative performance.
Specific Aim #3: evaluate different TCP and tourniquet times in relation to post-operative pain and complications of short-term, intermediate, and long-term followup.
Specific Aim #4: evaluate different TCP and tourniquet times in relation to post-operative function of short-term, intermediate, and long-term followup.
详细描述
The overall goal of the project is to evaluate the relationship of two variables: 1) tourniquet cuff pressure (TCP); and 2) tourniquet time (i.e. duration of inflation) during primary TKA relative to three categories of outcomes: 1) intraoperative performance; 2) post-operative pain and complications; and 3) post-operative complications.
Design
This study will use a randomized controlled trial that is double-blinded. The co-investigator, Mark Nazal, along with the principal investigator, Dr. Maxwell Langfitt, will work with the Orthopaedic Clinic Research Coordinator to recruit around 146 patients. Mark Nazal will then randomize these patients into one of six tourniquet cuff pressure (TCP) groups:
- 220 mmHg 4) 300 mmHg
- 250 mmHg 5) 325 mmHg
- 275 mmHg 6) 350 mmHg
The primary TKA procedure will be performed by one of the three fellowship-trained orthopedic surgeons at Wake Forest Baptist Hospital (Dr. Maxwell Langfitt, Dr. Jason Lang, and Dr. John Shields). The orthopedic surgeon and the patient will be blinded to the TCP assignment and will not be told what tourniquet pressure is being applied. The OR nursing team will be told what the patient's assigned TCP is in order to perform the actual inflation.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 80 years old
- •primary TKA, not revision
排除标准
- •systolic blood pressure (BP) ≥ 170 mmHg
- •one-staged bilateral TKA or stages less than three months apart
- •history of peripheral vascular disease
- •history of thromboembolism
研究组 & 干预措施
220 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 220 mmHg.
干预措施: Tourniquet Cuff Pressure (Procedure)
250 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 250 mmHg
干预措施: Tourniquet Cuff Pressure (Procedure)
275 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 275 mmHg
干预措施: Tourniquet Cuff Pressure (Procedure)
300 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 300 mmHg
干预措施: Tourniquet Cuff Pressure (Procedure)
325 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 325 mmHg
干预措施: Tourniquet Cuff Pressure (Procedure)
350 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 350 mmHg
干预措施: Tourniquet Cuff Pressure (Procedure)
结局指标
主要结局
Postoperative Pain
时间窗: Postoperative Day 1 through two weeks
Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes
次要结局
- Range of Motion(2-week follow-up)
- Intra-operative Bloodlessness(Intraoperative)
- Estimated Blood Loss(Postoperative Day 2)
- Quadriceps Strength(2-week follow-up through 12-week follow-up)
- Need for Revision of Total Knee Arthroplasty(One Year Follow-up)
- Ability to Ambulate(Postoperative Day 1 through Postoperative Day 2)
- Number of Participants With Wound Healing Issues(Postoperative Day 1 through 12 week follow-up)
- Need for Manipulation Under Anesthesia(6-week follow-up through 12-week follow-up)