Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA
- Conditions
- Knee Arthropathy
- Interventions
- Other: Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquetOther: Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time
- Registration Number
- NCT03942939
- Lead Sponsor
- University of Louisville
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B - TKA with tourniquet Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet 50 arms: subjects will receive a tourniquet during TKA surgery. A - TKA with short tourniquet time Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time 50 arms: subjects will receive a tourniquet with a short tourniquet time during TKA surgery. Short tourniquet time is defined in this study as the release of the tourniquet after the initial exposure, resulting in a total tourniquet time of only 10-15 minutes.
- Primary Outcome Measures
Name Time Method Knee Society Score 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 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) 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 outcome measure will be taken 6 weeks (± 2 weeks) postoperatively Ability to rise from a chair independently (Yes/No)
Amount of narcotic medication utilized 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 outcome measure will be taken 6 weeks (± 2 weeks) postoperatively Use of an ambulatory assistive device (Yes/No)
Incidence of postop transfusion 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) 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 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 outcome measure will be taken 6 weeks (± 2 weeks) postoperatively Distance that patient is able to walk, as measured in feet
Return to driving outcome measure will be taken 6 weeks (± 2 weeks) postoperatively Return to driving (Yes/No)
Level of Patient Satisfaction: 5-point Likert scale 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 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 outcome measure will be taken at 2 weeks postoperatively Total Operative Time as defined in minutes
Estimated Blood Loss (EBL) 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) 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
Quadriceps Function 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 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
- Secondary Outcome Measures
Name Time Method Number of Participants with postoperative complications outcome measure will be taken at 1 year (± 2 months) postoperatively Number of Participants with postoperative complications. A postoperative complication is defined as any diagnosis or condition that necessitates a re-operation on the surgical knee
Trial Locations
- Locations (1)
Jewish Hospital
🇺🇸Louisville, Kentucky, United States