Clinical trial NCT04992052: Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty
Official title: A Prospective, Randomized, Single-blinded Superiority Study to Evaluate Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Knee Replacement
Keywords: Knee arthroplasty
Total knee replacement
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Loss
timeFrame: Blood loss is measured the morning of postoperative day 1.
Secondary outcomes:
measure: Knee Society Scoring System
timeFrame: 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.
Other outcomes:
Locations:
city: Syosset
country: United States
facility: Syosset Hospital
state: New York
Study officials:
affiliation: Syosset Hospital, Northwell Health
name: Eugene Krauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.