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Completed

NCT Number: NCT03942939

Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

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.

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Key information

Conditions

Knee Arthropathy

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish Hospital

Louisville, Kentucky, 40202, United States

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 8, 2019
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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