Total Knee Replacement
Conditions
Keywords
Knee arthroplasty, Total knee replacement
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.
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 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.
Interventions
DEVICEBone 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
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United States
Participant flow
Recruitment details
The study was terminated early due to slow enrollment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Control Arm This arm will serve as the control group. Bone wax will not be used in this group. | 23 |
| Total | 52 |
Baseline characteristics
| Characteristic | Treatment Arm | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 8 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 21 Participants | 17 Participants | 38 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 23 |
| other Total, other adverse events | 0 / 29 | 0 / 23 |
| serious Total, serious adverse events | 0 / 29 | 0 / 23 |
Outcome results
Primary
Blood Loss
To determine if there is a change in blood volume loss between the two study arms.
Time frame: Blood loss is measured the morning of postoperative day 1.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Blood Loss | 810.48 mililiters | Standard Deviation 342.47 |
| Control Arm | Blood Loss | 905.36 mililiters | Standard Deviation 371.92 |
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.
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.
Population: 7 patients in the treatment arm and 4 patients in the control arm did not complete the postoperative knee society score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Knee Society Scoring System | 62.55 score on a scale | Standard Deviation 19.42 |
| Control Arm | Knee Society Scoring System | 56.32 score on a scale | Standard Deviation 15.36 |