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Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

Primary Purpose

Knee Arthropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time
Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Knee Arthropathy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is over the age of 21
  2. Patient is scheduled to undergo a unilateral, cementless primary RA-TKA, secondary to osteoarthritis
  3. Surgical approach is subvastus approach
  4. Patient's BMI (body mass index) is less than 40 at time of surgery.
  5. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents
  6. Patient is able to read and speak English

Exclusion Criteria:

  1. Patient is under the age of 21
  2. Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis)
  3. Patient is scheduled to undergo a bilateral TKA surgery
  4. Patient BMI is > 40
  5. Patient is unable to read and speak English

Sites / Locations

  • Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A - TKA with short tourniquet time

B - TKA with tourniquet

Arm Description

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.

50 arms: subjects will receive a tourniquet during TKA surgery.

Outcomes

Primary Outcome Measures

Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
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.
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.
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.
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
Amount of narcotic medication utilized
Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value).
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.
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.
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.
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.
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.
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Distance that patient is able to walk
Distance that patient is able to walk, as measured in feet
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Return to driving
Return to driving (Yes/No)
Return to driving
Return to driving (Yes/No)
Level of Patient Satisfaction: 5-point Likert scale
Level of Patient Satisfaction as measured using a 5-point Likert scale
Level of Patient Satisfaction: 5-point Likert scale
Level of Patient Satisfaction as measured using a 5-point Likert scale
Quadriceps Function
Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)
Quadriceps Function
Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)
Quadriceps Function
Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA)
total length of hospital stay
total length of hospital stay as defined by number of days from date of surgery to date of discharge
Dates of postoperative exams
Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam
Dates of postoperative exams
Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam
Dates of postoperative exams
Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam
Incidence of postop transfusion
Incidence of postop transfusion as defined by one or more transfusions of blood to the subject postoperatively
Change in creatinine level (CKMB)
Change in CKMB (creatinine level) as defined by the CKMB values recorded in the participant's lab report
Change in hemoglobin level (HgB)
Change in HgB as defined by the HgB values recorded in the participant's lab report
Operative Time
Total Operative Time as defined in minutes
Estimated Blood Loss (EBL)
Estimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc).

Secondary Outcome Measures

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

Full Information

First Posted
May 3, 2019
Last Updated
November 2, 2020
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT03942939
Brief Title
Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA
Official Title
Is TKA With Short Tourniquet Time Superior to TKA With Tourniquet Use in Primary Robotic Assisted TKA? A Prospective, Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
December 17, 2019 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - TKA with short tourniquet time
Arm Type
Experimental
Arm Description
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.
Arm Title
B - TKA with tourniquet
Arm Type
Active Comparator
Arm Description
50 arms: subjects will receive a tourniquet during TKA surgery.
Intervention Type
Other
Intervention Name(s)
Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
Intervention Description
Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
Primary Outcome Measure Information:
Title
Knee Society Score
Description
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)
Title
Knee Society Score
Description
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
Title
Knee Society Score
Description
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
Title
WOMAC Score
Description
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)
Title
WOMAC Score
Description
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
Title
WOMAC Score
Description
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
Title
Active range-of-motion (ROM)
Description
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)
Title
Active range-of-motion (ROM)
Description
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
Title
Active range-of-motion (ROM)
Description
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
Title
Amount of narcotic medication utilized
Description
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
Title
Amount of narcotic medication utilized
Description
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
Title
Amount of narcotic medication utilized
Description
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
Title
Amount of narcotic medication utilized
Description
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
Title
Amount of narcotic medication utilized
Description
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
Title
Visual Analog Scale
Description
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
Title
Visual Analog Scale
Description
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
Title
Visual Analog Scale
Description
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
Title
Visual Analog Scale
Description
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
Title
Visual Analog Scale
Description
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
Title
Distance that patient is able to walk
Description
Distance that patient is able to walk, as measured in feet
Time Frame
outcome measure will be taken 24 hours postoperatively
Title
Distance that patient is able to walk
Description
Distance that patient is able to walk, as measured in feet
Time Frame
outcome measure will be taken 48 hours postoperatively
Title
Distance that patient is able to walk
Description
Distance that patient is able to walk, as measured in feet
Time Frame
outcome measure will be taken 72 hours postoperatively
Title
Distance that patient is able to walk
Description
Distance that patient is able to walk, as measured in feet
Time Frame
outcome measure will be taken 2 weeks (± 4 days) postoperatively
Title
Distance that patient is able to walk
Description
Distance that patient is able to walk, as measured in feet
Time Frame
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Title
Ability to rise from a chair independently
Description
Ability to rise from a chair independently (Yes/No)
Time Frame
outcome measure will be taken 24 hours postoperatively
Title
Ability to rise from a chair independently
Description
Ability to rise from a chair independently (Yes/No)
Time Frame
outcome measure will be taken 48 hours postoperatively
Title
Ability to rise from a chair independently
Description
Ability to rise from a chair independently (Yes/No)
Time Frame
outcome measure will be taken 72 hours postoperatively
Title
Ability to rise from a chair independently
Description
Ability to rise from a chair independently (Yes/No)
Time Frame
outcome measure will be taken 2 weeks (± 4 days) postoperatively
Title
Ability to rise from a chair independently
Description
Ability to rise from a chair independently (Yes/No)
Time Frame
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Title
Use of an ambulatory assistive device
Description
Use of an ambulatory assistive device (Yes/No)
Time Frame
outcome measure will be taken 24 hours postoperatively
Title
Use of an ambulatory assistive device
Description
Use of an ambulatory assistive device (Yes/No)
Time Frame
outcome measure will be taken 48 hours postoperatively
Title
Use of an ambulatory assistive device
Description
Use of an ambulatory assistive device (Yes/No)
Time Frame
outcome measure will be taken 72 hours postoperatively
Title
Use of an ambulatory assistive device
Description
Use of an ambulatory assistive device (Yes/No)
Time Frame
outcome measure will be taken 2 weeks (± 4 days) postoperatively
Title
Use of an ambulatory assistive device
Description
Use of an ambulatory assistive device (Yes/No)
Time Frame
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Title
Return to driving
Description
Return to driving (Yes/No)
Time Frame
outcome measure will be taken 2 weeks (± 4 days) postoperatively
Title
Return to driving
Description
Return to driving (Yes/No)
Time Frame
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Title
Level of Patient Satisfaction: 5-point Likert scale
Description
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.
Title
Level of Patient Satisfaction: 5-point Likert scale
Description
Level of Patient Satisfaction as measured using a 5-point Likert scale
Time Frame
outcome measure will be taken 1 year (± 2 months) postoperatively
Title
Quadriceps Function
Description
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)
Title
Quadriceps Function
Description
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
Title
Quadriceps Function
Description
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
Title
total length of hospital stay
Description
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
Title
Dates of postoperative exams
Description
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
Title
Dates of postoperative exams
Description
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
Title
Dates of postoperative exams
Description
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
Title
Incidence of postop transfusion
Description
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
Title
Change in creatinine level (CKMB)
Description
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.
Title
Change in hemoglobin level (HgB)
Description
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.
Title
Operative Time
Description
Total Operative Time as defined in minutes
Time Frame
outcome measure will be taken at 2 weeks postoperatively
Title
Estimated Blood Loss (EBL)
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants with postoperative complications
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur L Malkani, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

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