Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

Not Applicable

Terminated

• Conditions: Total Knee Replacement
• Interventions: Device: Bone wax

• Registration Number: NCT04992052
• Lead Sponsor: Northwell Health

Brief Summary

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

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 Timeline

• Study Start: 2021-07-27
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Primary Completion: 2023-09-12
• Study Completion: 2023-09-12
• Results First Submitted: 2023-09-12
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-02
• Last Update Submitted: 2023-11-02
• Results First Posted: 2023-11-21
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm	Bone wax	This arm will have bone wax applied to the exposed cancellous surfaces of the bone.

Primary Outcome Measures

Name	Time	Method
Blood Loss	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.

Secondary Outcome Measures

Name	Time	Method
Knee Society Scoring System	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.

Trial Locations

Locations (1)

Syosset Hospital; 🇺🇸 Syosset, New York, United States