Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

Northwell Health

Status: Terminated

Conditions: Total Knee Replacement

Treatments: Device: Bone wax

Study type: Interventional

Funder types: Other

Identifiers

NCT04992052

21-0044-NSUH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Treatment arm

Active Comparator group

Description:

This arm will have bone wax applied to the exposed cancellous surfaces of the bone.

Treatment:

Device: Bone wax

Control Arm

No Intervention group

Description:

This arm will serve as the control group. Bone wax will not be used in this group.