Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Device: Bone wax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for primary unilateral total knee arthroplasty Preoperative Hemoglobin >11mg/dL Preoperative platelet count of >150,000 Exclusion Criteria: Patients unable to take aspirin or apixaban for VTE prophylaxis Allergy to any of the ingredients in bone wax (beeswax, paraffin, or isopropyl palmitate) Patients taking clopidogrel (Plavix), ticagrelor (Brilinta), or prasugrel (Effient) or any other antiplatelet medication (except for aspirin 81 mg) Patients unable to get IV Tranexamic Acid for any reason Patients requiring anticoagulant treatment prior to surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1 Bone wax applied to the exposed cancellous surfaces of the bone (treatment group). Arm 2 No bone wax. This group will serve as the control arm.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment arm<br>This arm will have bone wax applied to the exposed cancellous surfaces of the bone. | Device: Bone wax<br>* 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.<br>|
| No Intervention: Control Arm<br>This arm will serve as the control group. Bone wax will not be used in this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Loss | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee arthroplasty, Total knee replacement