MedTrace Logo

Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

NCT04992052 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-11-21

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Eugene Krauss, MD · Syosset Hospital, Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2023-09-12
Completion
2023-09-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04992052 on ClinicalTrials.gov