Tourniquet Pressure in Primary Total Knee Arthroplasty

November 27, 2018 updated by: Wake Forest University Health Sciences

The Effect of Tourniquet Time and Pressure on Intraoperative and Postoperative Performance, Function, Pain, and Complications in Primary Total Knee Arthroplasty.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The overall goal of the project is to evaluate the relationship of two variables: 1) tourniquet cuff pressure (TCP); and 2) tourniquet time (i.e. duration of inflation) during primary TKA relative to three categories of outcomes: 1) intraoperative performance; 2) post-operative pain and complications; and 3) post-operative complications.

Design

This study will use a randomized controlled trial that is double-blinded. The co-investigator, Mark Nazal, along with the principal investigator, Dr. Maxwell Langfitt, will work with the Orthopaedic Clinic Research Coordinator to recruit around 146 patients. Mark Nazal will then randomize these patients into one of six tourniquet cuff pressure (TCP) groups:

  1. 220 mmHg 4) 300 mmHg
  2. 250 mmHg 5) 325 mmHg
  3. 275 mmHg 6) 350 mmHg

The primary TKA procedure will be performed by one of the three fellowship-trained orthopedic surgeons at Wake Forest Baptist Hospital (Dr. Maxwell Langfitt, Dr. Jason Lang, and Dr. John Shields). The orthopedic surgeon and the patient will be blinded to the TCP assignment and will not be told what tourniquet pressure is being applied. The OR nursing team will be told what the patient's assigned TCP is in order to perform the actual inflation.

Data collection will include short-term data: post-operative day 1 (POD1), post-operative day 2 (POD2), and 2-week followup; intermediate data: 6-week and 12-week followup; and long-term data: 1-year followup.

The data collection for the first category of outcomes, intraoperative performance, will begin preoperatively, with the recording of baseline characteristics: circumference of the thigh in centimeters, baseline hemoglobin levels, and thromboembolism risk evaluation.

Intraoperative data will include: the type of anesthesia, the tourniquet size in centimeters, and whether or not a drain is inserted into the joint. The time of inflation and time of deflation will be noted in order to determine the duration of tourniquet inflation.

Then preincisional blood pressure (BP) will be measured and will continue to be noted every 15 minutes. At the conclusion of the procedure the surgeon will rate intraoperative bloodlessness on a four-point scale: 1-bloodless, 2-nearly bloodless, some bleeding; 3-bloody, tourniquet is no better than not using; or 4-venous tourniquet, tourniquet is making the procedure more difficult. Intraoperative bloodlessness is being used to determine the functionality and effectiveness of the tourniquet, surgical field visualization, and surgical site dryness.

The data collection for the second category of outcomes, post-operative pain and complications, will begin on post-operative day 1 (POD1). Post-operative (post-op) pain will be assessed using a 0-10 pain rating visual analog scale for both the knee and the thigh, and will be measured at POD1, POD2, 2-week followup, 6-week followup, 12-week followup, and 1-year followup. Next, wound healing issues will be assessed at POD1, POD2, 2-week followup, 6-week followup, and 12-week followup. Wound healing issues include blisters, wound drainage, thigh bruising, significant erythema, decreased peripheral pulse, evidence of decreased distal perfusion, or decreased distal sensation.13 Estimated total blood loss will be assessed at POD2 using pre-operative Hgb-level compared to Hgb-level on post-op day 2. The patient's estimated blood volume (EBV) will be calculated using Nadler's formulas for men and women.16

Then Meunier's formula will be used to calculate estimated blood loss.16 If a drain was inserted, then the volume of drainage will be measured at POD1. Finally, aseptic loosing of the implant leading to the need for revision will be assessed at 1-year followup.

The data collection for the third category of outcomes, post-operative function, will begin at POD1. Ability to ambulate will be measured in distance by feet at POD1 and POD2. Furthermore, assessment of any use of assisted device for ambulation (wheelchair, walker, 4-point cane, and 1-point cane) will be done at POD1, POD2, 2-week followup, 6-week followup, 12-week followup and 1-year followup. Quadriceps strength and range of motion (ROM) will be recorded at 2-week followup, 6-week followup, and 12-week followup. Quadriceps strength will be measured on a 5-point scale, where 0 is no movement and 5 is full strength. ROM will be measured in degrees of motion. Next, the necessity of performing a manipulation under anesthesia (MUA) due to limited joint motion will be recorded at 6-week followup and 12-week followup. The type of PT will be recorded at 2-week followup, 6-week followup, and 12-week followup. Types of PT include out-patient PT, home health PT, PT rehabilitation, and skilled nursing facility PT.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Bermuda Run, North Carolina, United States, 27006
        • Davie Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Postoperative Day 1 through two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative Day 2
Range of Motion
Time Frame: 2-week follow-up
Measure degrees of knee flexion
2-week follow-up
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
Intraoperative
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
Postoperative Day 1 through 12 week follow-up
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
One Year Follow-up
Ability to Ambulate
Time Frame: Postoperative Day 1 through Postoperative Day 2
Distance Walked in Feet
Postoperative Day 1 through Postoperative Day 2
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
2-week follow-up through 12-week follow-up
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
6-week follow-up through 12-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Study Director: Martha Holden, manager
  • Principal Investigator: Maxwell K Langfitt, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

September 20, 2016

Study Completion (Actual)

September 20, 2016

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00038367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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