Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

NCT04992052 | Terminated Results FDA Device

• 1 other identifier: 21-0044-NSUH
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement

Keywords

Knee arthroplasty; Total knee replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Knee Society Scoring System

  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.

Study Arms (2)

Treatment arm

ACTIVE COMPARATOR

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

Device: Bone wax

Control Arm

NO INTERVENTION

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

Interventions

Bone wax DEVICE

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.

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for primary unilateral total knee arthroplasty
• Preoperative Hemoglobin \>11mg/dL
• Preoperative platelet count of \>150,000

You may not qualify if:

• Patients unable to take aspirin or apixaban for VTE prophylaxis
• Allergy to any of the ingredients in bone wax (beeswax, paraffin, or isopropyl palmitate)
• Patients taking clopidogrel (Plavix), ticagrelor (Brilinta), or prasugrel (Effient) or any other antiplatelet medication (except for aspirin 81 mg)
• Patients unable to get IV Tranexamic Acid for any reason
• Patients requiring anticoagulant treatment prior to surgery

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Syosset Hospital

Syosset, New York, 11791, United States

Location

Related Publications (3)

• 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.

  PMID: 33010755 BACKGROUND

• 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.

  PMID: 22065240 BACKGROUND

• 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.

  PMID: 28089184 RESULT

Limitations and Caveats

This study was terminated early due to poor enrollment. In order to do formal power calculation using a two-sample t-test at a significance level of 0.05, a sample size of 100 subjects would be needed to detect a difference in mean blood loss of about 150 mL to 200 mL between the control group and the treatment group. A blood loss of 150 mL to 200 mL is the value which the investigators consider to be clinically significant.

Results Point of Contact

• Title: Nancy Dengler, Clinical Research Nurse
• Organization: Northwell Health System

ndengler@northwell.edu

516-496-2637

Study Officials

• Eugene Krauss, MD

  Syosset Hospital, Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Orthopaedics, Syosset Hospital, Northwell Health System

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: July 27, 2021
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: November 21, 2023
• Results First Posted: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)