Is TKA With Short Tourniquet Time Superior to TKA With Tourniquet Use in Primary Robotic Assisted TKA? A Prospective, Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Knee Society Score
研究概览
简要总结
The goal of this prospective, randomized study is to compare the outcomes of patients undergoing Robotic Arm-Assisted TKA (RA-TKA) with the intraoperative use of a tourniquet to those undergoing RA-TKA with a short tourniquet time.
详细描述
The goal of this prospective, randomized study is to compare the outcomes of patients undergoing Robotic Arm-Assisted TKA (RA-TKA) with the intraoperative use of a tourniquet to those undergoing RA-TKA with a short tourniquet time. The primary objectives will be to compare the total duration of hospital stay, quadriceps function, and the amount of postoperative narcotics utilized and VAS pain levels. The secondary objective will be to compare variables of patient functionality at five postoperative intervals.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is over the age of 21
- •Patient is scheduled to undergo a unilateral, cementless primary RA-TKA, secondary to osteoarthritis
- •Surgical approach is subvastus approach
- •Patient's BMI (body mass index) is less than 40 at time of surgery.
- •Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents
- •Patient is able to read and speak English
排除标准
- •Patient is under the age of 21
- •Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis)
- •Patient is scheduled to undergo a bilateral TKA surgery
- •Patient BMI is > 40
- •Patient is unable to read and speak English
结局指标
主要结局
Knee Society Score
时间窗: outcome measure will be taken 1 year (± 2 months) postoperatively
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
WOMAC Score
时间窗: outcome measure will be taken 1 year (± 2 months) postoperatively
WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome.
Active range-of-motion (ROM)
时间窗: outcome measure will be taken 1 year (± 2 months) postoperatively
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Ability to rise from a chair independently
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Ability to rise from a chair independently (Yes/No)
Quadriceps Function
时间窗: outcome measure will be taken 1 year (± 2 months) postoperatively
Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)
Dates of postoperative exams
时间窗: outcome measure will be taken 1 year (± 2 months) postoperatively
Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam
Amount of narcotic medication utilized
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Use of an ambulatory assistive device
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Use of an ambulatory assistive device (Yes/No)
Incidence of postop transfusion
时间窗: outcome measure will be taken at 2 weeks postoperatively
Incidence of postop transfusion as defined by one or more transfusions of blood to the subject postoperatively
Change in creatinine level (CKMB)
时间窗: outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two.
Change in CKMB (creatinine level) as defined by the CKMB values recorded in the participant's lab report
Visual Analog Scale
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents "pain-free". A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, "the worst pain imaginable". Obviously, the lower the number, the better the outcome. There is no subscale.
Distance that patient is able to walk
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Distance that patient is able to walk, as measured in feet
Return to driving
时间窗: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Return to driving (Yes/No)
Level of Patient Satisfaction: 5-point Likert scale
时间窗: outcome measure will be taken 1 year (± 2 months) postoperatively
Level of Patient Satisfaction as measured using a 5-point Likert scale
total length of hospital stay
时间窗: outcome measure will be taken at 2 weeks postoperatively
total length of hospital stay as defined by number of days from date of surgery to date of discharge
Operative Time
时间窗: outcome measure will be taken at 2 weeks postoperatively
Total Operative Time as defined in minutes
Estimated Blood Loss (EBL)
时间窗: outcome measure will be taken at 2 weeks postoperatively
Estimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc).
Change in hemoglobin level (HgB)
时间窗: outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two.
Change in HgB as defined by the HgB values recorded in the participant's lab report
次要结局
- Number of Participants with postoperative complications(outcome measure will be taken at 1 year (± 2 months) postoperatively)
研究者
Arthur Malkani
Professor, Adult Reconstruction
University of Louisville