Tourniquet on Total Knee Arthroplasty

Impact on Tourniquet Use on Functional Outcomes and Complications After TKA

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.

Study Overview

• Status: Completed
• Conditions: Arthritis Knee
• Intervention / Treatment: Device: tourniquet; Device: No tourniquet

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tourniquet during surgery; Patients in this group get a tourniquet during surgery.	Device: tourniquet; tourniquet is a device used during total knee surgery.
Active Comparator: No Tourniquet during surgery; Patients in this group do not get a tourniquet during surgery.	Device: No tourniquet; tourniquet is a device used during total knee surgery, this group does not get one

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after TKA measured by pain survey on Focusmotion app	Effect of tourniquet use on pain after TKA	1 year
Pain after TKA measured by Washington University specific survey	Effect of tourniquet use on pain after TKA	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 year
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	1 year
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	1 year
Functional recovery measured by range of motion	Effect of tourniquet use on functional recovery after TKA measured by range of motion with FocusMotion brace	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality average time of REM sleep	Investigate sleep quality in post-operative period after TKA using fitbit tracker average time of REM sleep	3 months
Sleep quality time in bed	Investigate sleep quality in post-operative period after TKA using fitbit tracker average time in bed	3 months
Sleep quality average time of disturbances	Investigate sleep quality in post-operative period after TKA using fitbit tracker average time of disturbances	3 months
Sleep quality average time in light sleep	Investigate sleep quality in post-operative period after TKA using fitbit tracker average time in light sleep	3 months
total blood loss	effect of tourniquet use on total calculated blood loss after TKA	1 day

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Robert Barrack, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 201805014

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
• product manufactured in and exported from the U.S.: No