Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04992052
• Other study ID #: 21-0044-NSUH
• Status: Terminated
• Phase: N/A
• Start date: July 27, 2021
• Est. completion date: September 12, 2023

Study information

• Verified date: November 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

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.

Locations

Country	Name	City	State
United States	Syosset Hospital	Syosset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

Moo IH, Chen JYQ, Pagkaliwaga EH, Tan SW, Poon KB. Bone Wax Is Effective in Reducing Blood Loss After Total Knee Arthroplasty. J Arthroplasty. 2017 May;32(5):1483-1487. doi: 10.1016/j.arth.2016.12.028. Epub 2016 Dec 24. — View Citation

Noble PC, Scuderi GR, Brekke AC, Sikorskii A, Benjamin JB, Lonner JH, Chadha P, Daylamani DA, Scott WN, Bourne RB. Development of a new Knee Society scoring system. Clin Orthop Relat Res. 2012 Jan;470(1):20-32. doi: 10.1007/s11999-011-2152-z. — View Citation

Shin KH, Choe JH, Jang KM, Han SB. Use of bone wax reduces blood loss and transfusion rates after total knee arthroplasty. Knee. 2020 Oct;27(5):1411-1417. doi: 10.1016/j.knee.2020.07.074. Epub 2020 Aug 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.