Surgical Blood Loss
Conditions
Keywords
Total Knee Arthroplasty, Surgical Blood Loss, Electrocautery, Perioperative Blood Conservation
Brief summary
The purpose of this study is to investigate whether the saline-coupled bipolar sealer compared to the unipolar electrocautery provides superior hemostasis in patients undergoing primary unilateral total knee arthroplasty. This will be a prospective, randomized, single-blinded, non-inferiority study in patients scheduled for a primary unilateral total knee arthroplasty (TKA) with Dr. Eugene Krauss or Dr. Ayal Segal. The restriction of this study to two surgeons will limit variations in the outcomes being measured due to differences in surgical technique.
Detailed description
Total joint arthroplasty can result in significant blood loss. Minimizing blood loss has led to multiple blood conservation strategies in orthopaedic procedures. The use of unipolar electrocautery or the saline-coupled bipolar sealer are methods used to reduce intraoperative bleeding. Saline-coupled bipolar sealer technology initially demonstrated promising results in the literature when it was reported that this technology had superior efficacy by reducing blood loss and transfusion requirements in orthopaedic surgery. However, the saline-coupled bipolar sealer technology comes at a significantly higher cost when compared to the unipolar electrocautery. A bipolar electrode costs an additional $450.00 per case, whereas, the unipolar electrocautery catheter is included in all the pre-packaged orthopedic surgical trays. The added cost of the saline-coupled bipolar sealer was offset by the potential savings in the reduced need for blood transfusions. A single blood transfusion is estimated to be $750-$1200. This cost includes both the direct cost of the blood and the additional nursing time needed. Recent publications have challenged the superiority of the saline-coupled bipolar sealer in hemostasis. These randomized clinical trials (RCT) have not supported superiority of this method when compared to standard unipolar electrocautery and the continued use of the saline-coupled bipolar sealer has been questioned. The purpose of this study is to investigate whether the saline-coupled bipolar sealer compared to the unipolar electrocautery provides superior hemostasis in patients undergoing primary unilateral total knee arthroplasty. This will be a prospective, randomized, single-blinded, non-inferiority study in patients scheduled for a primary unilateral TKA with Dr. Eugene Krauss or Dr. Ayal Segal. The restriction of this study to two surgeons will limit variations in the outcomes being measured due to differences in surgical technique.
Interventions
DEVICESaline-coupled Bipolar Sealer
The Aquamantys® System is a commercially available device used routinely used in the operating room for a wide variety of surgical cases. It allows for temperatures to stay at approximately 100°C, nearly 200°C less than conventional devices, which produces a tissue effect without the charring associated with other methods. The temperature is sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels, resulting in the reduction in bleeding from both soft tissue and bone. The device can be used to spot coagulate vessels that are actively bleeding or to broadly paint tissue surfaces to prevent bleeding or treat active oozing.
DEVICEUnipolar electrocautery
The Coviden ForceTriad™ energy platform is a full-featured electrosurgical system that provides electrosurgical cutting and coagulation, bipolar functionality, and vessel sealing in a single generator.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients scheduled for primary unilateral total knee arthroplasty with Dr. Krauss or Dr. Segal 2. Preoperative Hemoglobin \>11mg/dL 3. Preoperative platelet count of \>150,000 4. Age \>18 5. Patient is freely able to provide consent 6. American Society of Anesthesiologists (ASA) classification I-III (Appendix J) 7. Patient willing to complete all study related procedures
Exclusion criteria
1. Patients allergic to aspirin 2. Patients with an intolerance to aspirin 3. Patients with a contraindication to Apixaban 4. Any patient who is not a candidate for venous thromboembolism (VTE) risk stratification according to the calculated Caprini Risk Assessment Score. This includes, but is not limited to, any patient who cannot be prescribed ASA 81 mg bid or Apixiban 2.5 mg bid for VTE prophylaxis 5. Patients who for any reason are not a candidate for the use of the monopolar electrocautery 6. History of venous thromboembolism (Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)) within 12 months prior to the date of surgery 7. Mitral valve replacement or aortic valve replacement with additional risk factor for stroke (atrial fibrillation, previous thromboembolism, left ventricular dysfunction, hypercoagulable conditions) 8. Active cancer 9. Inheritied thrombophilia, eg: Factor V Leiden, Protein C and S deficiencies, Antithrombin deficiency, Prothrombin 20210A mutations 10. Acquired thrombophilia, eg: Lupus anticoagulant, antiphospholipid antibody syndrome 11. Patients taking clopidogrel (Plavix), ticagrelor(Brilinta), or prasugrel (Effient) or any other antiplatelet medication (except for aspirin 81 mg) 12. Patients unable to get intravenous tranexamic acid (TXA) for any reason 13. Patients requiring anticoagulant treatment prior to surgery 14. History of stroke or trans-ischemic attack 15. Serum creatinine \> 2.8 mg/dl 16. History of hepatic failure 17. Any medical condition that in the opinion of the investigator would require special fluid management protocols during or after surgery 18. Allergy to TXA 19. Preoperative hemoglobin \< 11 20. Preoperative platelets \< 150,000 21. Blood transfusion within 1 month of surgery 22. ASA classification IV or V 23. Patients who are unwilling to undergo blood transfusion, if necessary 24. Evidence of active (systemic or local) infection at time of surgery 25. Patients who have habitual opioid use 26. Patients who have a psychiatric or mental illness which could impair the consent process or ability to complete patient-reported questionnaires 27. Fixed motor deficit affecting functional assessment of the knee 28. Patients unable to have spinal anesthesia 29. Patients receiving erythropoietin therapy for anemia 30. Patients who are unable to stop their daily aspirin, aspirin-like products, and/or non-steroidal anti-inflammatory agents 7 days prior to surgery for any reason 31. Patients with a contraindication for the pneumatic tourniquet applied in the operating room
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis | Postoperative day 1 | Postoperative day 1 estimated blood loss as calculated by the Gross' Formula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcomes | 8 weeks | Functional outcomes measured by the 2011 Knee Society Score. The Functional Activities section consists of 4 sub-sections with a total score ranging from 0-100 points. The higher the numerical value the better the outcome. The sub-sections consist of: (1)Walking and Standing 0-30 points (2)Standard Activities 0-30 points (3)Advanced Activities 0-25 points (4)Discretionary Knee Activities 0-15 points. |
| Wound Infection | 90 days postoperatively | Participants were assessed for any wound infection within 90 days of surgery. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the private office practice of the three surgeons who participated in the clinical trials. The first patient signed consent on May 7, 2019. The last patient was consented on 3/10/2021.
Pre-assignment details
47 patients were screen failures due to either the blood work not meeting the study enrollment criteria, an exclusion for spinal anesthesia, or the patient decided not to proceed with enrollment in the study.
Participants by arm
| Arm | Count |
|---|---|
| Saline-Coupled Bipolar Sealer Device: Saline-coupled Bipolar Sealer The Aquamantys® System is a commercially available device used routinely used in the operating room for a wide variety of surgical cases. It allows for temperatures to stay at approximately 100°C, nearly 200°C less than conventional devices, which produces a tissue effect without the charring associated with other methods. The temperature is sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels, resulting in the reduction in bleeding from both soft tissue and bone. The device can be used to spot coagulate vessels that are actively bleeding or to broadly paint tissue surfaces to prevent bleeding or treat active oozing.
Other Names:
Aquamantys System(TM) | 82 |
| Unipolar Electrocautery Device: Unipolar electrocautery The Coviden ForceTriad™ energy platform is a full-featured electrosurgical system that provides electrosurgical cutting and coagulation, bipolar functionality, and vessel sealing in a single generator.
Other Names:
Covidien ForceTriad(TM) | 82 |
| Total | 164 |
Baseline characteristics
| Characteristic | Unipolar Electrocautery | Total | Saline-Coupled Bipolar Sealer |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 46 Participants | 90 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 74 Participants | 38 Participants |
| Age, Continuous | 66.1 Years STANDARD_DEVIATION 8.9 | 65.1 Years STANDARD_DEVIATION 8.6 | 64.3 Years STANDARD_DEVIATION 8.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 82 participants | 164 participants | 82 participants |
| Sex: Female, Male Female | 45 Participants | 99 Participants | 54 Participants |
| Sex: Female, Male Male | 37 Participants | 65 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 82 |
| other Total, other adverse events | 1 / 82 | 3 / 82 |
| serious Total, serious adverse events | 0 / 82 | 0 / 82 |
Outcome results
Primary
Hemostasis
Postoperative day 1 estimated blood loss as calculated by the Gross' Formula
Time frame: Postoperative day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm | Hemostasis | 924 milliliters |
| Control Arm | Hemostasis | 1062 milliliters |
p-value: 0.1254t-test, 1 sided
Secondary
Functional Outcomes
Functional outcomes measured by the 2011 Knee Society Score. The Functional Activities section consists of 4 sub-sections with a total score ranging from 0-100 points. The higher the numerical value the better the outcome. The sub-sections consist of: (1)Walking and Standing 0-30 points (2)Standard Activities 0-30 points (3)Advanced Activities 0-25 points (4)Discretionary Knee Activities 0-15 points.
Time frame: 8 weeks
Population: 6 participants in the Treatment Arm-Saline-coupled bipolar sealer and 6 participants in the Control Arm-Unipolar electrocautery did not complete the Knee Society Score Questionnaire, therefore, only 76 patients in each of the arms were included in the statistical analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm | Functional Outcomes | 56.45 score on a scale |
| Control Arm | Functional Outcomes | 61.79 score on a scale |
p-value: <0.05t-test, 2 sided
Secondary
Wound Infection
Participants were assessed for any wound infection within 90 days of surgery.
Time frame: 90 days postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Wound Infection | 1 Number of events |
| Control Arm | Wound Infection | 3 Number of events |