Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04923724 |
| Other study ID # |
201805014 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2020 |
| Est. completion date |
November 30, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Washington University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
