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Tourniquet Pressure in Primary Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830087
Recruitment Status : Terminated (No patient follow-up)
First Posted : July 12, 2016
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

This proposed novel randomized control trial (RCT) seeks to address this gap in TKA protocol by gaining a better understanding of the relationship between tourniquet pressure and time, and intraoperative performance and post-operative outcomes. This study does not seek to answer the question of "tourniquet vs no tourniquet", but to seek a tourniquet usage that would maximize the intraoperative benefits for the surgeon and minimize the negative consequences for patient outcomes.

Specific Aim #1: enroll around 146 primary TKA patients.

Specific Aim #2: evaluate different tourniquet cuff pressures (TCP) and tourniquet times in relation to intraoperative performance.

Specific Aim #3: evaluate different TCP and tourniquet times in relation to post-operative pain and complications of short-term, intermediate, and long-term followup.

Specific Aim #4: evaluate different TCP and tourniquet times in relation to post-operative function of short-term, intermediate, and long-term followup.


Condition or disease Intervention/treatment Phase
Tourniquets Knee Arthroplasty, Total Knee Replacement, Total Procedure: Tourniquet Cuff Pressure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Tourniquet Time and Pressure on Intraoperative and Postoperative Performance, Function, Pain, and Complications in Primary Total Knee Arthroplasty.
Study Start Date : June 2016
Actual Primary Completion Date : September 20, 2016
Actual Study Completion Date : September 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: 220 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 220 mmHg.
Procedure: Tourniquet Cuff Pressure
Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.

Active Comparator: 250 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 250 mmHg
Procedure: Tourniquet Cuff Pressure
Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.

Active Comparator: 275 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 275 mmHg
Procedure: Tourniquet Cuff Pressure
Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.

Active Comparator: 300 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 300 mmHg
Procedure: Tourniquet Cuff Pressure
Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.

Active Comparator: 325 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 325 mmHg
Procedure: Tourniquet Cuff Pressure
Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.

Active Comparator: 350 mmHg tourniquet cuff pressure
Thigh tourniquet cuff inflated to 350 mmHg
Procedure: Tourniquet Cuff Pressure
Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.




Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: Postoperative Day 1 through two weeks ]
    Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes


Secondary Outcome Measures :
  1. Estimated Blood Loss [ Time Frame: Postoperative Day 2 ]
    Meunier's formula will be used to calculate estimated blood loss, comparing preoperative blood draw to postoperative day 2 blood draw.

  2. Range of Motion [ Time Frame: 2-week follow-up ]
    Measure degrees of knee flexion

  3. Intra-operative Bloodlessness [ Time Frame: Intraoperative ]

    four-point scale:

    • 1 = bloodless
    • 2 = nearly bloodless, some bleeding
    • 3 = bloody, tourniquet no better than not using
    • 4 = venous tourniquet, tourniquet making things worse

    Higher scores denotes worse outcome


  4. Number of Participants With Wound Healing Issues [ Time Frame: Postoperative Day 1 through 12 week follow-up ]
    Any wound issues including blisters, wound drainage, thigh bruising, significant erythema, decreased peripheral pulse, evidence of decreased distal perfusion, or decreased distal sensation

  5. Need for Revision of Total Knee Arthroplasty [ Time Frame: One Year Follow-up ]
    Number of participants that needed a revision was necessary within one year

  6. Ability to Ambulate [ Time Frame: Postoperative Day 1 through Postoperative Day 2 ]
    Distance Walked in Feet

  7. Quadriceps Strength [ Time Frame: 2-week follow-up through 12-week follow-up ]

    Six Point Strength Scale 0 - No muscle movement

    1. -Muscle movement, without movement at the joint
    2. -Movement at the joint, but not against gravity
    3. -Movement against gravity, but not against resistance
    4. -Movement against resistance, but less than full strength
    5. -Full Strength

    Higher scores denotes better outcome


  8. Need for Manipulation Under Anesthesia [ Time Frame: 6-week follow-up through 12-week follow-up ]
    Number of participants that needed a manipulation under anesthesia was necessary within 12 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18 - 80 years old
  2. primary TKA, not revision

Exclusion Criteria:

  1. systolic blood pressure (BP) ≥ 170 mmHg
  2. one-staged bilateral TKA or stages less than three months apart
  3. history of peripheral vascular disease
  4. history of thromboembolism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830087


Locations
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United States, North Carolina
Davie Medical Center
Bermuda Run, North Carolina, United States, 27006
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Study Director: Martha Holden Manager
Principal Investigator: Maxwell K Langfitt, MD Wake Forest University Health Sciences

Additional Information:
Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02830087    
Other Study ID Numbers: IRB00038367
First Posted: July 12, 2016    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Wake Forest University Health Sciences:
randomized controlled trial
tourniquet
tourniquet cuff pressure
total knee arthroplasty
total knee replacement
pain, postoperative
range of motion, articular
blood loss, surgical
muscle strength, quadriceps
walking
manipulation, orthopedic/therapeutic use
wound healing/surgery