Tourniquet on Total Knee Arthroplasty
Primary Purpose
Arthritis Knee
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tourniquet
No tourniquet
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis Knee
Eligibility Criteria
Inclusion Criteria:
- Age 18 and up
- Primary unilateral TKA
- BMI<45
- Primary diagnosis of osteoarthritis
- Patient has a iOS or Android smartphone capable of running FitBit and FocusMotion applications
Exclusion Criteria:
- Revision TKA
- Bilateral TKA
- Pregnancy
- Prisoners
- Pre-existing functionally-limiting neurologic disorder
- Narcotic dependence, defined as oxycodone/hydrocodone use >5days/week
- History of unprovoked VTE/PE
- Inability to complete baseline functional testing
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tourniquet during surgery
No Tourniquet during surgery
Arm Description
Patients in this group get a tourniquet during surgery.
Patients in this group do not get a tourniquet during surgery.
Outcomes
Primary Outcome Measures
Pain after TKA measured by pain survey on Focusmotion app
Effect of tourniquet use on pain after TKA
Pain after TKA measured by Washington University specific survey
Effect of tourniquet use on pain after TKA
Secondary Outcome Measures
Functional recovery measured by oxford knee score scale
Effect of tourniquet use on functional recovery after TKA. Score each question (item) from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).
Functional recovery measured by forgotten joint score
Effect of tourniquet use on functional recovery after TKA. Scale measures how much patient is aware of their joint after surgery. lower score is not aware, higher score is most aware of the joint
Functional recovery measured by normal knee survey
Effect of tourniquet use on functional recovery after TKA measured by a score of 0-100, 100 being knee feels normal, 0 means knee does not feel normal
Functional recovery measured by range of motion
Effect of tourniquet use on functional recovery after TKA measured by range of motion with FocusMotion brace
Full Information
NCT ID
NCT04923724
First Posted
May 19, 2021
Last Updated
January 24, 2023
Sponsor
Washington University School of Medicine
Collaborators
Zimmer Biomet
1. Study Identification
Unique Protocol Identification Number
NCT04923724
Brief Title
Tourniquet on Total Knee Arthroplasty
Official Title
Impact on Tourniquet Use on Functional Outcomes and Complications After TKA
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is determine the effect on novel pressure-regulating tourniquet use on pain, functional recovery, sleep and total blood loss following total knee arthroplasty.
Detailed Description
Functional recovery after total knee arthroplasty (TKA) has seen dramatic improvement over the past 20 years through advances in surgical technique, implant design, perioperative pain management strategies, and physical therapy protocols. Tourniquet use during TKA, however, remains controversial due to conflicting reports in the literature on these benefits and risks of its use. Reported advantages of tourniquet use include improved visualization of the surgical field and decreased intraoperative blood loss. Reported disadvantages of tourniquet use include increased postoperative pain and slower functional recovery as a direct result of the pressure of the tourniquet on the thigh during the procedure.
Traditionally with tourniquet use during TKA, the limb is exsanguinated and the tourniquet is raised to a fixed, pressure at the beginning of the case, typically 250mmHg to 350mmHg, and let down after closure. A novel tourniquet design that adjusts the tourniquet pressure in real-time based on intraoperative patient blood pressure measurements. This design may allow for the tourniquet to be inflated at a lower mean pressure while still maintaining efficacy.
A prospective study comparing total blood loss, pain and functional recovery after TKA using this novel tourniquet design, design (Zimmer A.T.S.® 4000TS Automatic Tourniquet System, with disposable contour cuffs) and TKA without tourniquet would further the current literature. Total blood loss will be calculated by previously validated methods. Pain and functional recovery will be closely monitored throughout the postoperative period using a patient wearable activity tracker (FitBit Inspire HR) and a smartphone-based patient engagement platform with integrated digital surveys paired with smart-brace based home PT assessments (FocusMotion).Pain and functional recovery will be closely monitored throughout the postoperative period using a patient wearable activity tracker (FitBit Inspire HR) and a smartphone-based patient engagement platform with integrated digital surveys paired with smart-brace based home PT assessments (FocusMotion). Applying this technology to the proposed study can help identify problematic pain that is not appreciable during admission; given the fact that markers of inflammation and myocyte damage increase over time until at least post-operative day 3, it is possible that TKAs performed under tourniquet may have pain and narcotic requirements not appreciated with short-stay admissions . The proposed study will further the literature on pain and narcotic use in the early time period after TKA, and will help identify if tourniquet has an effect on these variables.
Furthermore, sleep quality is a component of functional recovery and is correlated with pain. Knee osteoarthritis affects general quality of life by increasing sleep disturbance and nighttime wakening, and this is correlated with the pre-operative radiographic severity of disease. Sleep quality is affected in the immediate post-operative period after TKA as well, but improves by 3-6 months post-operatively . The proposed study would be the largest prospective study investigating the effect of TKA on pain and sleep quality, as well as being the first to investigate tourniquet use as a factor affecting sleep quality and pain. The proposed study would be the first to collect both subjective and objective data on the subject, using validated survey measurements as well as the data collected by the Fitbit Inspire HR device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are put into 2 study groups. One group gets a tourniquet during surgery and one group does not.
Masking
Participant
Masking Description
Participants do not know which group they are in.
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tourniquet during surgery
Arm Type
Active Comparator
Arm Description
Patients in this group get a tourniquet during surgery.
Arm Title
No Tourniquet during surgery
Arm Type
Active Comparator
Arm Description
Patients in this group do not get a tourniquet during surgery.
Intervention Type
Device
Intervention Name(s)
tourniquet
Intervention Description
tourniquet is a device used during total knee surgery.
Intervention Type
Device
Intervention Name(s)
No tourniquet
Intervention Description
tourniquet is a device used during total knee surgery, this group does not get one
Primary Outcome Measure Information:
Title
Pain after TKA measured by pain survey on Focusmotion app
Description
Effect of tourniquet use on pain after TKA
Time Frame
1 year
Title
Pain after TKA measured by Washington University specific survey
Description
Effect of tourniquet use on pain after TKA
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Functional recovery measured by oxford knee score scale
Description
Effect of tourniquet use on functional recovery after TKA. Score each question (item) from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).
Time Frame
1 year
Title
Functional recovery measured by forgotten joint score
Description
Effect of tourniquet use on functional recovery after TKA. Scale measures how much patient is aware of their joint after surgery. lower score is not aware, higher score is most aware of the joint
Time Frame
1 year
Title
Functional recovery measured by normal knee survey
Description
Effect of tourniquet use on functional recovery after TKA measured by a score of 0-100, 100 being knee feels normal, 0 means knee does not feel normal
Time Frame
1 year
Title
Functional recovery measured by range of motion
Description
Effect of tourniquet use on functional recovery after TKA measured by range of motion with FocusMotion brace
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Sleep quality average time of REM sleep
Description
Investigate sleep quality in post-operative period after TKA using fitbit tracker average time of REM sleep
Time Frame
3 months
Title
Sleep quality time in bed
Description
Investigate sleep quality in post-operative period after TKA using fitbit tracker average time in bed
Time Frame
3 months
Title
Sleep quality average time of disturbances
Description
Investigate sleep quality in post-operative period after TKA using fitbit tracker average time of disturbances
Time Frame
3 months
Title
Sleep quality average time in light sleep
Description
Investigate sleep quality in post-operative period after TKA using fitbit tracker average time in light sleep
Time Frame
3 months
Title
total blood loss
Description
effect of tourniquet use on total calculated blood loss after TKA
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 and up
Primary unilateral TKA
BMI<45
Primary diagnosis of osteoarthritis
Patient has a iOS or Android smartphone capable of running FitBit and FocusMotion applications
Exclusion Criteria:
Revision TKA
Bilateral TKA
Pregnancy
Prisoners
Pre-existing functionally-limiting neurologic disorder
Narcotic dependence, defined as oxycodone/hydrocodone use >5days/week
History of unprovoked VTE/PE
Inability to complete baseline functional testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Barrack
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Tourniquet on Total Knee Arthroplasty
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