Total Knee ReplacementNCT04992052

Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

A study testing Bone wax in people with Total Knee Replacement, run by Northwell Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Total Knee Replacement
What is being tested?: Bone wax
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 27 Jul 2021to 12 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Syosset Hospital
Syosset, New York, 11791

Other trials in United States

About this study

Official title: A Prospective, Randomized, Single-blinded Superiority Study to Evaluate Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty

Read the 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

Conditions: Total Knee Replacement
Being tested: Bone wax
Keywords: Knee arthroplasty, Total knee replacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bone waxDevice
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.

Study groups in NCT04992052
Study group	Role	What they receive
Treatment arm	Active comparator	This arm will have bone wax applied to the exposed cancellous surfaces of the bone. Receives: Device: Bone wax
Control Arm	No intervention	This arm will serve as the control group. Bone wax will not be used in this group.

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Loss
To determine if there is a change in blood volume loss between the two study arms.
Measured: Blood loss is measured the morning of postoperative day 1.

Secondary outcomes (1)

Knee Society Scoring System
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 202112 Sep 2023

First posted5 Aug 2021
Study start27 Jul 2021
Primary completion12 Sep 2023
Study completion12 Sep 2023

Why it stopped: Poor Enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
More trials run by Northwell HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04992052
Sponsor's protocol ID: 21-0044-NSUH
Status last verified: Nov 2023
First submitted: 28 Jul 2021
Last updated: 21 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 33010755
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.
PubMed 22065240
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.
PubMed 28089184

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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All Total Knee Replacement trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Single-blinded Superiority Study to Evaluate Bone Wax Use for Hemostasis During Primary Unilateral Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT04992052
Acronym / sponsor ID: 21-0044-NSUH
Conditions: Total Knee Replacement
Keywords: Knee arthroplasty, Total knee replacement
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor Enrollment
Enrolment: 52 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Study start: 27 Jul 2021 (actual)
Primary completion: 12 Sep 2023 (actual)
Study completion: 12 Sep 2023 (actual)
First posted: 5 Aug 2021 (actual)
Results: Posted 21 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
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	Type	Receives
Treatment arm	Active comparator	Device: Bone waxThis arm will have bone wax applied to the exposed cancellous surfaces of the bone.
Control Arm	No intervention	–This arm will serve as the control group. Bone wax will not be used in this group.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bone waxThe 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.	Device	Treatment arm

Primary outcome

Blood Loss
Time frame: Blood loss is measured the morning of postoperative day 1.
To determine if there is a change in blood volume loss between the two study arms.

1 secondary outcome

Knee Society Scoring System
Time frame: 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.

Results and safety

Results posted to the registry on 21 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Arm	29	29
Control Arm	23	23

Primary outcome: Blood Loss

Time frame: Blood loss is measured the morning of postoperative day 1.. Mean (Standard Deviation). Unit: mililiters

Measure	Treatment Arm n = 29	Control Arm n = 22
Value	810.48 (342.47)	905.36 (371.92)

Population analysed: One patient in the control arm did not have any blood work done on postoperative day 1, therefore, the blood loss analysis could not be calculated.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Patients were followed for 90 days after the day of surgery for any adverse events or device related events.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Control Arm	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33010755Shin 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.
Background: PubMed 22065240Noble 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.
Results publication: PubMed 28089184Moo 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.
Individual participant dataSharing planned: No

Related trials for Total Knee Replacement

Not yet recruiting
Application of Perinatal Derivatives in Total Knee Arthroplasty
Total Knee Arthroplasty, Knee Osteoarthristis
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
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Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eugene Krauss, MD principal investigator

Syosset Hospital, Northwell Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bone wax in people with Total Knee Replacement, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Loss (time frame: Blood loss is measured the morning of postoperative day 1.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04992052, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.