Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

N/ATerminatedNCT04992052

Northwell Health52 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Total Knee Replacement

Interventions

Bone waxDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Syosset Hospital

Syosset, New York, United States

Outcomes

Primary Outcomes

Blood Loss

To determine if there is a change in blood volume loss between the two study arms.

Time frame: Blood loss is measured the morning of postoperative day 1.

Secondary Outcomes

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.

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.

Data from ClinicalTrials.gov

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