Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

November 2, 2023 updated by: Eugene Krauss, Northwell Health

A Prospective, Randomized, Single-blinded Superiority Study to Evaluate Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

The purpose of this study is to assess whether the application of bone wax to exposed cancellous bone, after the cemented implants are in place, will provide superior hemostasis in total knee arthroplasty (TKA) patients compared to patients who do not have the bone wax applied. Hemostasis will be assessed by calculating blood loss using the Hb-balance formula.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Total joint arthroplasty can result in significant blood loss. Postoperative anemia has been associated with prolonged length of stay and increased hospital costs.1 Minimizing blood loss has led to multiple blood conservation strategies in orthopaedic procedures.

Bone wax is a well-known topical hemostatic agent comprised of a mixture of beeswax, paraffin, and isopropyl palmitate. This inexpensive agent works by sealing the bleeding site and tamponades bleeding from the cancellous bone. Bone wax can be precisely applied evenly and stops bone bleeding immediately upon application.2

The purpose of this study is to assess whether the application of bone wax to exposed cancellous bone, after the cemented implants are in place, will provide superior hemostasis in total knee arthroplasty (TKA) patients compared to patients who do not have the bone wax applied. Hemostasis will be assessed by calculating blood loss using the Hb-balance formula.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syosset, New York, United States, 11791
        • Syosset Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients scheduled for primary unilateral total knee arthroplasty
  2. Preoperative Hemoglobin >11mg/dL
  3. Preoperative platelet count of >150,000

Exclusion Criteria:

  1. Patients unable to take aspirin or apixaban for VTE prophylaxis
  2. Allergy to any of the ingredients in bone wax (beeswax, paraffin, or isopropyl palmitate)
  3. Patients taking clopidogrel (Plavix), ticagrelor (Brilinta), or prasugrel (Effient) or any other antiplatelet medication (except for aspirin 81 mg)
  4. Patients unable to get IV Tranexamic Acid for any reason
  5. Patients requiring anticoagulant treatment prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment arm
This arm will have bone wax applied to the exposed cancellous surfaces of the bone.
Device: Bone wax
The surgeons will apply the bone wax to the exposed cancellous bone after the implant has been cemented in place in patients randomized to the treatment arm.
No Intervention: Control Arm
This arm will serve as the control group. Bone wax will not be used in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Loss
Time Frame: Blood loss is measured the morning of postoperative day 1.
To determine if there is a change in blood volume loss between the two study arms.
Blood loss is measured the morning of postoperative day 1.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Scoring System
Time Frame: The Knee Society Score was collected within two months prior to the day of surgery and on postoperative day 56 with a collection window of +/- 2 weeks.
To determine if there is a change in patient functional outcomes, as measured by the Knee Society Scoring System, between the two study arms. The minimum and maximum score for this scale ranges from 0-100. A higher score means a better outcome.
The Knee Society Score was collected within two months prior to the day of surgery and on postoperative day 56 with a collection window of +/- 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Eugene Krauss, MD, Syosset Hospital, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Actual)

September 12, 2023

Study Completion (Actual)

September 12, 2023

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-0044-NSUH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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