Knee ArthropathyNCT03942939
Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA
A study testing Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time and Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet in people with Knee Arthropathy, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Knee Arthropathy
- What is being tested?
- Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time and Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2019to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Arthropathy
- Being tested
- Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time, Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet timeOther
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.
Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquetOther
Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
| Study group | Role | What they receive |
|---|---|---|
| A - TKA with short tourniquet time | Experimental | 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. Receives: Other: Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time |
| B - TKA with tourniquet | Active comparator | 50 arms: subjects will receive a tourniquet during TKA surgery. Receives: Other: Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: outcome measure will be taken 24 hours postoperatively
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Measured: outcome measure will be taken 48 hours postoperatively
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Measured: outcome measure will be taken 72 hours postoperatively
Ability to rise from a chair independently
Ability to rise from a chair independently (Yes/No)
Measured: 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)
Measured: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Measured: outcome measure will be taken 24 hours postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Measured: outcome measure will be taken 48 hours postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Measured: outcome measure will be taken 72 hours postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Measured: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Use of an ambulatory assistive device
Use of an ambulatory assistive device (Yes/No)
Measured: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Return to driving
Return to driving (Yes/No)
Measured: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Return to driving
Return to driving (Yes/No)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: outcome measure will be taken at 2 weeks postoperatively
Secondary outcomes (1)
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
Measured: outcome measure will be taken at 1 year (± 2 months) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start27 Aug 2019
- Primary completion17 Dec 2019
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Malkani, University of Louisville
- Investigators
- Arthur L Malkani, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942939
- Sponsor's protocol ID
- 19.0365
- Status last verified
- Nov 2020
- First submitted
- 3 May 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is TKA With Short Tourniquet Time Superior to TKA With Tourniquet Use in Primary Robotic Assisted TKA? A Prospective, Randomized Study.
- ClinicalTrials.gov ID
- NCT03942939
- Acronym / sponsor ID
- 19.0365
- Conditions
- Knee Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - TKA with short tourniquet time | Experimental | Other: Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time50 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. |
| B - TKA with tourniquet | Active comparator | Other: Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet50 arms: subjects will receive a tourniquet during TKA surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet timePrimary 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. | Other | A - TKA with short tourniquet time |
| Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquetPrimary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet | Other | B - TKA with tourniquet |
Primary outcome
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.
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.
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.
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.
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)
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)
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).
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).
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.
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.
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 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
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
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
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)
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)
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)
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)
Return to driving
Time frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
Return to driving (Yes/No)
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 at 6 weeks (± 2 weeks) postoperatively.
Level of Patient Satisfaction as measured using a 5-point Likert scale
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
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)
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)
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
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
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
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
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
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).
1 secondary outcome
Number of Participants with postoperative complications
Time frame: outcome measure will be taken at 1 year (± 2 months) postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur L Malkani, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time and Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet in people with Knee Arthropathy, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score (time frame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)). The study lists 50 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.