Tourniquet on Total Knee Arthroplasty

NCT04923724 | Completed Results FDA Device

• 1 other identifier: 201805014
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis Knee

Outcome Measures

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

  1 year

Secondary Outcomes (3)

• Functional Recovery Measured by Oxford Knee Score Scale

  1 year

• Functional Recovery Measured by Forgotten Joint Score

  1 year

• Functional Recovery Measured by Normal Knee Survey

  1 year

Other Outcomes (2)

• Hours of Sleep Per Night Postoperatively

  3 months

• Total Blood Loss

  1 day

Study Arms (2)

Tourniquet during surgery

ACTIVE COMPARATOR

Patients in this group get a tourniquet during surgery.

Device: tourniquet

No Tourniquet during surgery

ACTIVE COMPARATOR

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

Device: No tourniquet

Interventions

tourniquet DEVICE

tourniquet is a device used during total knee surgery.

Tourniquet during surgery

No tourniquet DEVICE

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

No Tourniquet during surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Washington University School of Medicine

Creve Coeur, Missouri, 63141, United States

Location

MeSH Terms

Interventions

Tourniquets

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Venessa Riegler
• Organization: Washington University School of Medicine

rieglerv@wustl.edu

314-362-1721

Study Officials

• Robert Barrack

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not know which group they are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are put into 2 study groups. One group gets a tourniquet during surgery and one group does not.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 11, 2021
• Study Start: November 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 27, 2024
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)