An interventional study of Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time and Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet in Knee Arthropathy, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by University of Louisville · Not applicable, Interventional, and Basic science
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 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.
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Exclusion Criteria:
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.
Other: Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time
50 arms: subjects will receive a tourniquet during TKA surgery.
Other: Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time. 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 Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Time frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Time frame: outcome measure will be taken 1 year (± 2 months) postoperatively
WOMAC Score
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.
Time frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
WOMAC Score
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.
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
WOMAC Score
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.
Time frame: outcome measure will be taken 1 year (± 2 months) postoperatively
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Time frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Time frame: outcome measure will be taken 1 year (± 2 months) postoperatively
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Time frame: outcome measure will be taken 24 hours postoperatively
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Time frame: outcome measure will be taken 48 hours postoperatively
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Time frame: outcome measure will be taken 72 hours postoperatively
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Time frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Visual Analog Scale
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.
Time frame: outcome measure will be taken 24 hours postoperatively
Visual Analog Scale
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.
Time frame: outcome measure will be taken 48 hours postoperatively
Visual Analog Scale
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.
Time frame: outcome measure will be taken 72 hours postoperatively
Visual Analog Scale
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.
Time frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Visual Analog Scale
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.
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Time frame: outcome measure will be taken 24 hours postoperatively
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Time frame: outcome measure will be taken 48 hours postoperatively
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Time frame: outcome measure will be taken 72 hours postoperatively
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Time frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Time frame: outcome measure will be taken 24 hours postoperatively
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Time frame: outcome measure will be taken 48 hours postoperatively
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Time frame: outcome measure will be taken 72 hours postoperatively
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Time frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Time frame: outcome measure will be taken 24 hours postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Time frame: outcome measure will be taken 48 hours postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Time frame: outcome measure will be taken 72 hours postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Time frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Return to driving
Return to driving (Yes/No)
Time frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Return to driving
Return to driving (Yes/No)
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Level of Patient Satisfaction: 5-point Likert scale
Level of Patient Satisfaction as measured using a 5-point Likert scale
Time frame: outcome measure will be taken at 6 weeks (± 2 weeks) postoperatively.
Level of Patient Satisfaction: 5-point Likert scale
Level of Patient Satisfaction as measured using a 5-point Likert scale
Time frame: outcome measure will be taken 1 year (± 2 months) postoperatively
Quadriceps Function
Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)
Time frame: outcome measure will be taken at 2 weeks (± 4 days)
Quadriceps Function
Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Quadriceps Function
Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)
Time frame: outcome measure will be taken 1 year (± 2 months) postoperatively
total length of hospital stay
total length of hospital stay as defined by number of days from date of surgery to date of discharge
Time frame: outcome measure will be taken at 2 weeks postoperatively
Dates of postoperative exams
Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam
Time frame: outcome measure will be taken at 2 weeks (± 4 days) postoperatively
Dates of postoperative exams
Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Dates of postoperative exams
Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam
Time frame: outcome measure will be taken 1 year (± 2 months) postoperatively
Incidence of postop transfusion
Incidence of postop transfusion as defined by one or more transfusions of blood to the subject postoperatively
Time frame: outcome measure will be taken at 2 weeks postoperatively
Change in creatinine level (CKMB)
Change in CKMB (creatinine level) as defined by the CKMB values recorded in the participant's lab report
Time frame: outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two.
Change in hemoglobin level (HgB)
Change in HgB as defined by the HgB values recorded in the participant's lab report
Time frame: outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two.
Operative Time
Total Operative Time as defined in minutes
Time frame: outcome measure will be taken at 2 weeks postoperatively
Estimated Blood Loss (EBL)
Estimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc).
Time frame: outcome measure will be taken at 2 weeks postoperatively
Number of Participants with postoperative complications
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
Time frame: outcome measure will be taken at 1 year (± 2 months) postoperatively
Plan to share: No
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