Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthropathy
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time; 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.
Active Comparator: B - TKA with tourniquet; 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 the use of a tourniquet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2019
• Primary Completion (Actual): December 17, 2019
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 19.0365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No