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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

Clinicaltrials.gov identifier NCT03942939

Recruitment Status Recruiting

First Posted May 8, 2019

Last update posted October 10, 2019

Study Description

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.

  • Condition or Disease: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
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Basic Science
  • Official Title: Is TKA With Short Tourniquet Time Superior to TKA With Tourniquet Use in Primary Robotic Assisted TKA? A Prospective, Randomized Study.
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: June 2020
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 5. 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.
  • 6. 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.
  • 7. 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)
  • 8. 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)
  • 9. 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)
  • 10. 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).
  • 11. 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).
  • 12. 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).
  • 13. 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).
  • 14. 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).
  • 15. 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.
  • 16. 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.
  • 17. 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.
  • 18. 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.
  • 19. 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.
  • 20. 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
  • 21. 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
  • 22. 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
  • 23. 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
  • 24. 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
  • 25. 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)
  • 26. 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)
  • 27. 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)
  • 28. 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)
  • 29. 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)
  • 30. Use of an ambulatory assistive device [ Time Frame: outcome measure will be taken 24 hours postoperatively ]
    Use of an ambulatory assistive device (Yes/No)
  • 31. Use of an ambulatory assistive device [ Time Frame: outcome measure will be taken 48 hours postoperatively ]
    Use of an ambulatory assistive device (Yes/No)
  • 32. Use of an ambulatory assistive device [ Time Frame: outcome measure will be taken 72 hours postoperatively ]
    Use of an ambulatory assistive device (Yes/No)
  • 33. 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)
  • 34. 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)
  • 35. Return to driving [ Time Frame: outcome measure will be taken 2 weeks (± 4 days) postoperatively ]
    Return to driving (Yes/No)
  • 36. Return to driving [ Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively ]
    Return to driving (Yes/No)
  • 37. 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
  • 38. 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
  • 39. 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)
  • 40. 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)
  • 41. 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)
  • 42. 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
  • 43. 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
  • 44. 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
  • 45. 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
  • 46. 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
  • 47. 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
  • 48. 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
  • 49. Operative Time [ Time Frame: outcome measure will be taken at 2 weeks postoperatively ]
    Total Operative Time as defined in minutes
  • 50. 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).
  • Secondary Outcome Measures: 1. 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
Eligibility Criteria
  • Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Langan S Smith, BS 5025878222 ext 753 langanssmith@kentuckyonehealth.org

Locations

United States, Kentucky
Jewish Hospital
Louisville

Sponsors and Collaborators

University of Louisville

Investigators

Principal Investigator: Arthur L Malkani, MD University of Louisville

More Information
  • Responsible Party: University of Louisville
  • ClinicalTrials.gov Identifier: NCT03942939 History of Changes
  • Other Study ID Numbers: 19.0365
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: October 10, 2019
  • Last Verified: October 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Joint Diseases