Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

• Sponsor: Northwell Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04992052
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20.1
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Replacement	Device: Bone wax	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Double (Participant, Care Provider)
• Masking Description: Blinding of the principal investigator and operating staff is not possible. However, all attempts will be made to keep this information from the hospital staff caring for the patients in the postoperative period. The patient and the postoperative hospital staff will be blinded to the treatment arm. The OR staff will be trained not to discuss this information with the patient. During the transition of care from the OR to the Post Anesthetic Care Unit (PACU) the treatment arm will not be included in the verbal patient report. The lack of this information is not required to effectively manage the patient in the postoperative period and will not affect patient care. Postoperatively medical care is managed by the hospitalist, medical doctors specializing in the care of hospitalized patients.
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Single-blinded Superiority Study to Evaluate Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty
• Actual Study Start Date: Jul 27, 2021
• Anticipated Primary Completion Date: Jan 30, 2023
• Anticipated Study Completion Date: Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment arm This arm will have bone wax applied to the exposed cancellous surfaces of the bone.	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.
No Intervention: Control Arm This arm will serve as the control group. Bone wax will not be used in this group.

Outcome Measures

Primary Outcome Measures

1. Blood Loss [Blood loss is measured in the morning prior to receiving anticoagulant treatment.]

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

Secondary Outcome Measures

1. Knee Society Scoring System [Preoperatively and 8 weeks postoperatively]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Syosset Hospital	Syosset	New York	United States	11791

Sponsors and Collaborators

• Northwell Health

Investigators

• Principal Investigator: Eugene Krauss, MD, Syosset Hospital, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Eugene Krauss, Director of Orthopaedics, Syosset Hospital, Northwell Health System, Northwell Health
• ClinicalTrials.gov Identifier: NCT04992052
• Other Study ID Numbers: 21-0044-NSUH
• First Posted: Aug 5, 2021
• Last Update Posted: Sep 8, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Eugene Krauss, Director of Orthopaedics, Syosset Hospital, Northwell Health System, Northwell Health: Knee arthroplasty; Total knee replacement
• Additional relevant MeSH terms: Bone wax

Study Results

No Results Posted as of Sep 8, 2021