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CompletedNCT04923724Updated May 15, 2025Results posted

Tourniquet on Total Knee Arthroplasty

An interventional study of tourniquet and No tourniquet in Arthritis Knee, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2020, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Arthritis Knee

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03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 165 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,764 studies on the registry; 270 are open to participants now.

Of its 325 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
165 participants (actual)

Study arms

  • Active comparator
    Tourniquet during surgery

    Patients in this group get a tourniquet during surgery.

    Device: tourniquet

  • Active comparator
    No Tourniquet during surgery

    Patients in this group do not get a tourniquet during surgery.

    Device: No tourniquet

Interventions

  • Devicetourniquet

    tourniquet is a device used during total knee surgery.

  • DeviceNo tourniquet

    tourniquet is a device used during total knee surgery, this group does not get one

06

What researchers measure

Primary outcomes

  1. Pain After TKA Measured by VAS Pain Survey on Focusmotion App

    Effect of tourniquet use on pain after TKA, 0-10 scale with 10 being higher pain, VAS pain survey

    Time frame: 1 year

Secondary outcomes

  1. 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).

    Time frame: 1 year

  2. 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. a total of 12 questions are answered asking about awareness of the knee joint. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48\*100) 0:Represents the worst possible score, indicating the highest level of joint awareness and the least ability to forget. 100:Represents the best possible score, indicating the lowest level of joint awareness and the greatest ability to forget

    Time frame: 1 year

  3. 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

    Time frame: 1 year

Other outcomes

  1. Hours of Sleep Per Night Postoperatively

    Investigate sleep quality in post-operative period after TKA using fitbit tracker average hours of sleep at night

    Time frame: 3 months

  2. Total Blood Loss

    effect of tourniquet use on total calculated blood loss after TKA. this is calculated by change in hemoglobin in g/dL from preop to periop.

    Time frame: 1 day

07

Results

Posted May 15, 2025

Participant flow

Participant flow — Overall Study
MilestoneTourniquet During SurgeryNo Tourniquet During Surgery
Started8283
Completed5758
Not completed2525

Outcome measures

PrimaryPain After TKA Measured by VAS Pain Survey on Focusmotion App

Effect of tourniquet use on pain after TKA, 0-10 scale with 10 being higher pain, VAS pain survey

Time frame:
1 year
Reported as:
Mean · score on a scale
Pain After TKA Measured by VAS Pain Survey on Focusmotion App
score on a scaleTourniquet During SurgeryNo Tourniquet During Surgery
Pain After TKA Measured by VAS Pain Survey on Focusmotion App2.8 ± 1.52.6 ± 1.8
SecondaryFunctional 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).

Time frame:
1 year
Reported as:
Mean · score on a scale
Functional Recovery Measured by Oxford Knee Score Scale
score on a scaleTourniquet During SurgeryNo Tourniquet During Surgery
Functional Recovery Measured by Oxford Knee Score Scale43.0 ± 6.2841.37 ± 8.84
SecondaryFunctional 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. a total of 12 questions are answered asking about awareness of the knee joint. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48\*100) 0:Represents the worst possible score, indicating the highest level of joint awareness and the least ability to forget. 100:Represents the best possible score, indicating the lowest level of joint awareness and the greatest ability to forget

Time frame:
1 year
Reported as:
Mean · score on a scale
Functional Recovery Measured by Forgotten Joint Score
score on a scaleTourniquet During SurgeryNo Tourniquet During Surgery
Functional Recovery Measured by Forgotten Joint Score68.4 ± 28.270.9 ± 77.4
SecondaryFunctional 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

Time frame:
1 year
Reported as:
Mean · score on a scale
Functional Recovery Measured by Normal Knee Survey
score on a scaleTourniquet During SurgeryNo Tourniquet During Surgery
Functional Recovery Measured by Normal Knee Survey79.3 ± 9081.5 ± 20.1
Other pre-specifiedHours of Sleep Per Night Postoperatively

Investigate sleep quality in post-operative period after TKA using fitbit tracker average hours of sleep at night

Time frame:
3 months
Reported as:
Mean · hours of sleep
Hours of Sleep Per Night Postoperatively
hours of sleepTourniquet During SurgeryNo Tourniquet During Surgery
Hours of Sleep Per Night Postoperatively5.41 ± 2.236.47 ± 1.63
Other pre-specifiedTotal Blood Loss

effect of tourniquet use on total calculated blood loss after TKA. this is calculated by change in hemoglobin in g/dL from preop to periop.

Time frame:
1 day
Reported as:
Mean · g/dL hemoglobin
Total Blood Loss
g/dL hemoglobinTourniquet During SurgeryNo Tourniquet During Surgery
Total Blood Loss13.9 ± 1.411.5 ± 1.3

Adverse events

Collected over Ae's collected up to 1 year.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tourniquet During Surgery1/57 (1.8%)1/57 (1.8%)0/57 (0%)
No Tourniquet During Surgery0/58 (0%)0/58 (0%)0/58 (0%)
Most frequent serious events
Most frequent serious events
EventTourniquet During SurgeryNo Tourniquet During Surgery
urinary retention lower abdominal and back painHepatobiliary disorders1/570/58

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Tourniquet During SurgeryNo Tourniquet During SurgeryTotal
<=18 years000
Between 18 and 65 years433982
>=65 years141933
Age, Continuous
Age, Continuous(years)Tourniquet During SurgeryNo Tourniquet During SurgeryTotal
Mean63.4 (18 to 80)64.6 (18 to 80)64 (18 to 80)
Sex: Female, Male
Sex: Female, Male(Participants)Tourniquet During SurgeryNo Tourniquet During SurgeryTotal
Female223456
Male352459
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Tourniquet During SurgeryNo Tourniquet During SurgeryTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Tourniquet During SurgeryNo Tourniquet During SurgeryTotal
United States5758115
08

Study locations

1 site
  • Washington University School of Medicine
    Creve Coeur, Missouri 63141, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 18, 2021
  • Informed consent form · Jul 21, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04923724
Lead sponsor
Washington University School of Medicine
Collaborators
Zimmer Biomet
Responsible party
Sponsor
First posted
Jun 11, 2021
Start date
Nov 1, 2020
Primary completion
Nov 30, 2023
Completion
Nov 27, 2024
Results posted
May 15, 2025
Last update
May 15, 2025

Study contacts

Robert Barrack
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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