Is TKA With Short Tourniquet Time Superior to TKA With Tourniquet Use in Primary Robotic Assisted TKA? A Prospective, Randomized Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Louisville
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- WOMAC Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
B - TKA with tourniquet
50 arms: subjects will receive a tourniquet during TKA surgery.
Intervention: Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet (Other)
A - TKA with 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.
Intervention: Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time (Other)
Outcomes
Primary Outcomes
WOMAC Score
Time Frame: 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.
Knee Society Score
Time Frame: 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.
Active range-of-motion (ROM)
Time Frame: 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
Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Ability to rise from a chair independently (Yes/No)
Quadriceps Function
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Use of an ambulatory assistive device (Yes/No)
Incidence of postop transfusion
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Distance that patient is able to walk, as measured in feet
Return to driving
Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Return to driving (Yes/No)
Level of Patient Satisfaction: 5-point Likert scale
Time Frame: 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
Time Frame: 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
Time Frame: outcome measure will be taken at 2 weeks postoperatively
Total Operative Time as defined in minutes
Estimated Blood Loss (EBL)
Time Frame: 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)
Time Frame: 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
Knee Society Score
Time Frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Knee Society Score
Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
WOMAC Score
Time Frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
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.
WOMAC Score
Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) 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)
Time Frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Active range-of-motion (ROM)
Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Amount of narcotic medication utilized
Time Frame: outcome measure will be taken 24 hours postoperatively
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Amount of narcotic medication utilized
Time Frame: outcome measure will be taken 48 hours postoperatively
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Amount of narcotic medication utilized
Time Frame: outcome measure will be taken 72 hours postoperatively
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Amount of narcotic medication utilized
Time Frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Visual Analog Scale
Time Frame: outcome measure will be taken 24 hours 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.
Visual Analog Scale
Time Frame: outcome measure will be taken 48 hours 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
Time Frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Distance that patient is able to walk, as measured in feet
Visual Analog Scale
Time Frame: outcome measure will be taken 72 hours 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.
Visual Analog Scale
Time Frame: outcome measure will be taken 2 weeks (± 4 days) 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
Time Frame: outcome measure will be taken 24 hours postoperatively
Distance that patient is able to walk, as measured in feet
Distance that patient is able to walk
Time Frame: outcome measure will be taken 48 hours postoperatively
Distance that patient is able to walk, as measured in feet
Distance that patient is able to walk
Time Frame: outcome measure will be taken 72 hours postoperatively
Distance that patient is able to walk, as measured in feet
Ability to rise from a chair independently
Time Frame: outcome measure will be taken 24 hours postoperatively
Ability to rise from a chair independently (Yes/No)
Ability to rise from a chair independently
Time Frame: outcome measure will be taken 48 hours postoperatively
Ability to rise from a chair independently (Yes/No)
Ability to rise from a chair independently
Time Frame: outcome measure will be taken 72 hours postoperatively
Ability to rise from a chair independently (Yes/No)
Ability to rise from a chair independently
Time Frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Ability to rise from a chair independently (Yes/No)
Use of an ambulatory assistive device
Time Frame: outcome measure will be taken 24 hours postoperatively
Use of an ambulatory assistive device (Yes/No)
Use of an ambulatory assistive device
Time Frame: outcome measure will be taken 48 hours postoperatively
Use of an ambulatory assistive device (Yes/No)
Use of an ambulatory assistive device
Time Frame: outcome measure will be taken 72 hours postoperatively
Use of an ambulatory assistive device (Yes/No)
Use of an ambulatory assistive device
Time Frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Use of an ambulatory assistive device (Yes/No)
Return to driving
Time Frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Return to driving (Yes/No)
Level of Patient Satisfaction: 5-point Likert scale
Time Frame: outcome measure will be taken at 6 weeks (± 2 weeks) postoperatively.
Level of Patient Satisfaction as measured using a 5-point Likert scale
Quadriceps Function
Time Frame: outcome measure will be taken at 2 weeks (± 4 days)
Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)
Quadriceps Function
Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) 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
Time Frame: outcome measure will be taken at 2 weeks (± 4 days) postoperatively
Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam
Dates of postoperative exams
Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam
Secondary Outcomes
- Number of Participants with postoperative complications(outcome measure will be taken at 1 year (± 2 months) postoperatively)
Investigators
Arthur Malkani
Professor, Adult Reconstruction
University of Louisville