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Poor Enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Active Comparator | This 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Krauss, MD | Syosset Hospital, Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syosset Hospital | Syosset | New York | 11791 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33010755 | Background | 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. | |
| 22065240 | 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. |
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The study was terminated early due to slow enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | This arm will have bone wax applied to the exposed cancellous surfaces of the bone. 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. |
| FG001 | Control Arm | This arm will serve as the control group. Bone wax will not be used in this group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | This arm will have bone wax applied to the exposed cancellous surfaces of the bone. 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. |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Loss | To determine if there is a change in blood volume loss between the two study arms. | 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. | Posted | Mean | Standard Deviation | mililiters | Blood loss is measured the morning of postoperative day 1. |
|
Patients were followed for 90 days after the day of surgery for any adverse events or device related events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | This arm will have bone wax applied to the exposed cancellous surfaces of the bone. 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Dengler, Clinical Research Nurse | Northwell Health System | 516-496-2637 | ndengler@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2022 | Sep 12, 2023 | Prot_SAP_000.pdf |
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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.
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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.
| 28089184 | Result | 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. |
This arm will serve as the control group. Bone wax will not be used in this group. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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This arm will serve as the control group. Bone wax will not be used in this group.
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| Secondary | 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. | 7 patients in the treatment arm and 4 patients in the control arm did not complete the postoperative knee society score. | Posted | Mean | Standard Deviation | score on a scale | 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. |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Control Arm | This arm will serve as the control group. Bone wax will not be used in this group. | 0 | 23 | 0 | 23 | 0 | 23 |
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