Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty
NCT ID: NCT04992052
Last Updated: 2023-11-21
Study Results
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View full resultsBasic Information
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TERMINATED
NA
52 participants
INTERVENTIONAL
2021-07-27
2023-09-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Arm 2 No bone wax. This group will serve as the control arm.
TREATMENT
DOUBLE
Study Groups
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Treatment arm
This arm will have bone wax applied to the exposed cancellous surfaces of the bone.
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.
Control Arm
This arm will serve as the control group. Bone wax will not be used in this group.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Preoperative Hemoglobin \>11mg/dL
3. Preoperative platelet count of \>150,000
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Northwell Health
OTHER
Responsible Party
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Eugene Krauss
Director of Orthopaedics, Syosset Hospital, Northwell Health System
Principal Investigators
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Eugene Krauss, MD
Role: PRINCIPAL_INVESTIGATOR
Syosset Hospital, Northwell Health
Locations
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Syosset Hospital
Syosset, New York, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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21-0044-NSUH
Identifier Type: -
Identifier Source: org_study_id
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