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.
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
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 group | Role | What they receive |
|---|---|---|
| Tourniquet during surgery | Active comparator | Patients in this group get a tourniquet during surgery. Receives: Device: tourniquet |
| No Tourniquet during surgery | Active comparator | Patients 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.
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)
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
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
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.
- First posted11 Jun 2021
- Study start1 Nov 2020
- Primary completion30 Nov 2023
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Robert Barrack, Principal investigator, Washington University School of Medicine
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Tourniquet Use on Functional Outcomes and Complications After TKA
- ClinicalTrials.gov ID
- NCT04923724
- Acronym / sponsor ID
- 201805014
- Conditions
- Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Posted 15 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients are put into 2 study groups. One group gets a tourniquet during surgery and one group does not.
| Arm | Type | Receives |
|---|---|---|
| Tourniquet during surgery | Active comparator | Device: tourniquetPatients in this group get a tourniquet during surgery. |
| No Tourniquet during surgery | Active comparator | Device: No tourniquetPatients in this group do not get a tourniquet during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Revision TKA
- Bilateral TKA
- Pregnancy
- Prisoners
- Pre-existing functionally-limiting neurologic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tourniquettourniquet is a device used during total knee surgery. | Device | Tourniquet during surgery |
| No tourniquettourniquet is a device used during total knee surgery, this group does not get one | Device | No Tourniquet during surgery |
Primary outcome
Pain After TKA Measured by VAS Pain Survey on Focusmotion App
Time frame: 1 year
Effect of tourniquet use on pain after TKA, 0-10 scale with 10 being higher pain, VAS pain survey
3 secondary outcomes
Functional Recovery Measured by Oxford Knee Score Scale
Time frame: 1 year
Functional Recovery Measured by Forgotten Joint Score
Time frame: 1 year
Functional Recovery Measured by Normal Knee Survey
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Barrack principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
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.