Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

November 2, 2020 updated by: Arthur Malkani, University of Louisville

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
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.
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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.
outcome measure will be taken 1 year (± 2 months) postoperatively
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.
outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
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.
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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.
outcome measure will be taken 1 year (± 2 months) postoperatively
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)
outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
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)
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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)
outcome measure will be taken 1 year (± 2 months) postoperatively
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).
outcome measure will be taken 24 hours postoperatively
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).
outcome measure will be taken 48 hours postoperatively
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).
outcome measure will be taken 72 hours postoperatively
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).
outcome measure will be taken 2 weeks (± 4 days) postoperatively
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).
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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.
outcome measure will be taken 24 hours postoperatively
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.
outcome measure will be taken 48 hours postoperatively
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.
outcome measure will be taken 72 hours postoperatively
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.
outcome measure will be taken 2 weeks (± 4 days) postoperatively
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.
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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
outcome measure will be taken 24 hours postoperatively
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
outcome measure will be taken 48 hours postoperatively
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
outcome measure will be taken 72 hours postoperatively
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
outcome measure will be taken 2 weeks (± 4 days) postoperatively
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
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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)
outcome measure will be taken 24 hours postoperatively
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)
outcome measure will be taken 48 hours postoperatively
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)
outcome measure will be taken 72 hours postoperatively
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)
outcome measure will be taken 2 weeks (± 4 days) postoperatively
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)
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Use of an ambulatory assistive device
Time Frame: outcome measure will be taken 24 hours postoperatively
Use of an ambulatory assistive device (Yes/No)
outcome measure will be taken 24 hours postoperatively
Use of an ambulatory assistive device
Time Frame: outcome measure will be taken 48 hours postoperatively
Use of an ambulatory assistive device (Yes/No)
outcome measure will be taken 48 hours postoperatively
Use of an ambulatory assistive device
Time Frame: outcome measure will be taken 72 hours postoperatively
Use of an ambulatory assistive device (Yes/No)
outcome measure will be taken 72 hours postoperatively
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)
outcome measure will be taken 2 weeks (± 4 days) postoperatively
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)
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Return to driving
Time Frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Return to driving (Yes/No)
outcome measure will be taken 2 weeks (± 4 days) postoperatively
Return to driving
Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Return to driving (Yes/No)
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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
outcome measure will be taken at 6 weeks (± 2 weeks) postoperatively.
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
outcome measure will be taken 1 year (± 2 months) postoperatively
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)
outcome measure will be taken at 2 weeks (± 4 days)
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)
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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)
outcome measure will be taken 1 year (± 2 months) postoperatively
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
outcome measure will be taken at 2 weeks postoperatively
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
outcome measure will be taken at 2 weeks (± 4 days) postoperatively
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
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
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
outcome measure will be taken 1 year (± 2 months) postoperatively
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
outcome measure will be taken at 2 weeks 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
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)
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
outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two.
Operative Time
Time Frame: outcome measure will be taken at 2 weeks postoperatively
Total Operative Time as defined in minutes
outcome measure will be taken at 2 weeks postoperatively
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).
outcome measure will be taken at 2 weeks postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with postoperative complications
Time Frame: outcome measure will be taken at 1 year (± 2 months) postoperatively
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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