Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is TKA With Short Tourniquet Time Superior to TKA With Tourniquet Use in Primary Robotic Assisted TKA? A Prospective, Randomized Study.

Conditions
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Knee Arthropathy

Intervention / Treatment
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* Other: Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time
* Other: Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - TKA with short tourniquet time<br>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<br>* 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.<br>|
| Active Comparator: B - TKA with tourniquet<br>50 arms: subjects will receive a tourniquet during TKA surgery. | Other: Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet<br>* Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome. | 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. | 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. | 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. | 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. | 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. | 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) | 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) | 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) | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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) | outcome measure will be taken 24 hours postoperatively | 
| Ability to rise from a chair independently | Ability to rise from a chair independently (Yes/No) | outcome measure will be taken 48 hours postoperatively | 
| Ability to rise from a chair independently | Ability to rise from a chair independently (Yes/No) | outcome measure will be taken 72 hours postoperatively | 
| Ability to rise from a chair independently | Ability to rise from a chair independently (Yes/No) | 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) | outcome measure will be taken 6 weeks (± 2 weeks) postoperatively | 
| Use of an ambulatory assistive device | Use of an ambulatory assistive device (Yes/No) | outcome measure will be taken 24 hours postoperatively | 
| Use of an ambulatory assistive device | Use of an ambulatory assistive device (Yes/No) | outcome measure will be taken 48 hours postoperatively | 
| Use of an ambulatory assistive device | Use of an ambulatory assistive device (Yes/No) | outcome measure will be taken 72 hours postoperatively | 
| Use of an ambulatory assistive device | Use of an ambulatory assistive device (Yes/No) | outcome measure will be taken 2 weeks (± 4 days) postoperatively | 
| Use of an ambulatory assistive device | Use of an ambulatory assistive device (Yes/No) | outcome measure will be taken 6 weeks (± 2 weeks) postoperatively | 
| Return to driving | Return to driving (Yes/No) | outcome measure will be taken 2 weeks (± 4 days) postoperatively | 
| Return to driving | Return to driving (Yes/No) | 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 | 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 | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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). | outcome measure will be taken at 2 weeks postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | outcome measure will be taken at 1 year (± 2 months) postoperatively |