Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

NCT03942939 | Completed

• 1 other identifier: 19.0365
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, randomized study is to compare the outcomes of patients undergoing Robotic Arm-Assisted TKA (RA-TKA) with the intraoperative use of a tourniquet to those undergoing RA-TKA with a short tourniquet time.

Conditions

Knee Arthropathy

Outcome Measures

Primary Outcomes (50)

• 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 Outcomes (1)

• Number of Participants with postoperative complications

  outcome measure will be taken at 1 year (± 2 months) postoperatively

Study Arms (2)

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.

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.

Other: Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet

Interventions

Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time OTHER

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.

A - TKA with short tourniquet time

Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet OTHER

Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet

B - TKA with tourniquet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Study Officials

• Arthur L Malkani, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Adult Reconstruction

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 8, 2019
• Study Start: August 27, 2019
• Primary Completion: December 17, 2019
• Study Completion: July 15, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)