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Arthritis KneeNCT04923724

Tourniquet on Total Knee Arthroplasty

A study testing tourniquet and No tourniquet in people with Arthritis Knee, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis Knee
What is being tested?
tourniquet and No tourniquet
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteUnited States
Study dates
1 Nov 2020to 27 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Washington University School of Medicine

    Creve Coeur, Missouri, 63141

Other trials in United States

About this study

Official title: 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.

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.

Conditions
Arthritis Knee
Being tested
tourniquet, No tourniquet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tourniquetDevice

    tourniquet is a device used during total knee surgery.

  • No tourniquetDevice

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

Study groups in NCT04923724
Study groupRoleWhat they receive
Tourniquet during surgeryActive comparatorPatients in this group get a tourniquet during surgery.
Receives: Device: tourniquet
No Tourniquet during surgeryActive comparatorPatients in this group do not get a tourniquet during surgery.
Receives: Device: No tourniquet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Secondary outcomes (3)
  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).

    Measured: 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

    Measured: 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start1 Nov 2020
  3. Primary completion30 Nov 2023
  4. Study completion27 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients are put into 2 study groups. One group gets a tourniquet during surgery and one group does not.
Masking
Single blind
Who is masked
Participant
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04923724
Sponsor's protocol ID
201805014
Status last verified
May 2025
First submitted
19 May 2021
Last updated
15 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing tourniquet and No tourniquet in people with Arthritis Knee, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain After TKA Measured by VAS Pain Survey on Focusmotion App (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025; AzTrials last refreshed its copy on 2 Nov 2026.

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