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出境医 / 临床实验 / To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty

To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty

Study Description
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.

Condition or disease Intervention/treatment Phase
Surgical Blood Loss Device: Saline-coupled Bipolar Sealer Device: Unipolar electrocautery Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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.
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Single-blinded, Non-inferiority Study to Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer Compared to the Unipolar Electrocautery in Primary Unilateral Total Knee Arthroplasty
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Treatment Arm
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 Name: Aquamantys System(TM)
Active Comparator: Control Arm
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 Name: Covidien ForceTriad(TM)
Outcome Measures
Primary Outcome Measures :
  1. Hemostasis [ Time Frame: Postoperative day 1 to discharge from the hospital ]
    Perioperative estimated blood loss as calculated by the Gross' Formula


Secondary Outcome Measures :
  1. Functional outcomes [ Time Frame: 8 weeks ]
    Functional outcomes measured by the 2011 Knee Society Score

  2. Safety Profile [ Time Frame: 90 days postoperatively ]
    Device emergent adverse events within 90 days of the date of surgery


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Nancy Dengler, RN, MS 5164962637 ndengler@northwell.edu

Locations
Layout table for location information
United States, New York
Syosset Hospital Recruiting
Syosset, New York, United States, 11791
Contact: Nancy Dengler, RN    516-496-2637    ndengler@northwell.edu   
Sponsors and Collaborators
Northwell Health
Investigators
Layout table for investigator information
Principal Investigator: Eugene S. Krauss, MD Northwell Health
Tracking Information
First Submitted Date  ICMJE August 11, 2016
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE May 7, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		Hemostasis [ Time Frame: Postoperative day 1 to discharge from the hospital ]
Perioperative estimated blood loss as calculated by the Gross' Formula
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Functional outcomes [ Time Frame: 8 weeks ]
    Functional outcomes measured by the 2011 Knee Society Score
  • Safety Profile [ Time Frame: 90 days postoperatively ]
    Device emergent adverse events within 90 days of the date of surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer in Primary Unilateral Total Knee Arthroplasty
Official Title  ICMJE A Prospective, Randomized, Single-blinded, Non-inferiority Study to Evaluate the Safety and Efficacy of the Saline-coupled Bipolar Sealer Compared to the Unipolar Electrocautery in Primary Unilateral Total Knee Arthroplasty
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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.
Primary Purpose: Treatment
Condition  ICMJE Surgical Blood Loss
Intervention  ICMJE
  • 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 Name: Aquamantys System(TM)
  • 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 Name: Covidien ForceTriad(TM)
Study Arms  ICMJE
  • Experimental: Treatment Arm
    Saline-coupled bipolar sealer
    Intervention: Device: Saline-coupled Bipolar Sealer
  • Active Comparator: Control Arm
    Unipolar electrocautery
    Intervention: Device: Unipolar electrocautery
Publications *
  • Spahn DR, Goodnough LT. Alternatives to blood transfusion. Lancet. 2013 May 25;381(9880):1855-65. doi: 10.1016/S0140-6736(13)60808-9. Review.
  • Plymale MF, Capogna BM, Lovy AJ, Adler ML, Hirsh DM, Kim SJ. Unipolar vs bipolar hemostasis in total knee arthroplasty: a prospective randomized trial. J Arthroplasty. 2012 Jun;27(6):1133-7.e1. doi: 10.1016/j.arth.2011.09.016. Epub 2011 Nov 4.
  • Dunne JR, Malone D, Tracy JK, Gannon C, Napolitano LM. Perioperative anemia: an independent risk factor for infection, mortality, and resource utilization in surgery. J Surg Res. 2002 Feb;102(2):237-44.
  • Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.
  • Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. Review.
  • Tobias JD. Strategies for minimizing blood loss in orthopedic surgery. Semin Hematol. 2004 Jan;41(1 Suppl 1):145-56. Review.
  • Esler CN, Blakeway C, Fiddian NJ. The use of a closed-suction drain in total knee arthroplasty. A prospective, randomised study. J Bone Joint Surg Br. 2003 Mar;85(2):215-7.
  • Marulanda GA, Ulrich SD, Seyler TM, Delanois RE, Mont MA. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices. 2008 Mar;5(2):125-31. doi: 10.1586/17434440.5.2.125.
  • Weeden SH, Schmidt RH, Isabell G. Haemostatic efficacy of a bipolar sealing device in minimally invasive total knee arthroplasty. J Bone Joint Surg Br Proceedings 2009; 91-B:45.
  • Morris MJ, Berend KR, Lombardi AV Jr. Hemostasis in anterior supine intermuscular total hip arthroplasty: pilot study comparing standard electrocautery and a bipolar sealer. Surg Technol Int. 2010 Oct;20:352-6.
  • Morris MJ, Barrett M, Lombardi AV Jr, Tucker TL, Berend KR. Randomized blinded study comparing a bipolar sealer and standard electrocautery in reducing transfusion requirements in anterior supine intermuscular total hip arthroplasty. J Arthroplasty. 2013 Oct;28(9):1614-7. doi: 10.1016/j.arth.2013.01.032. Epub 2013 Mar 16.
  • Zeh A, Messer J, Davis J, Vasarhelyi A, Wohlrab D. The Aquamantys system--an alternative to reduce blood loss in primary total hip arthroplasty? J Arthroplasty. 2010 Oct;25(7):1072-7. doi: 10.1016/j.arth.2009.10.008. Epub 2010 Jan 22.
  • Strahovnik A, Fokter SK, Kotnik M. Comparison of drainage techniques on prolonged serous drainage after total hip arthroplasty. J Arthroplasty. 2010 Feb;25(2):244-8. doi: 10.1016/j.arth.2008.08.014. Epub 2008 Dec 4.
  • Johansson T, Engquist M, Pettersson LG, Lisander B. Blood loss after total hip replacement: a prospective randomized study between wound compression and drainage. J Arthroplasty. 2005 Dec;20(8):967-71.
  • Yang Y, Zhang LC, Xu F, Li J, Lv YM. Bipolar sealer not superior to standard electrocautery in primary total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2014 Oct 10;9:92. doi: 10.1186/s13018-014-0092-5.
  • Gibon E, Courpied JP, Hamadouche M. Total joint replacement and blood loss: what is the best equation? Int Orthop. 2013 Apr;37(4):735-9. doi: 10.1007/s00264-013-1801-0. Epub 2013 Feb 6. Review.
  • Eipe NP, Ponniah M. Perioperative blood loss assessment-how accurate? Indian J Anaesth. 2006;50(1):35-38
  • Barsoum WK, Klika AK, Murray TG, Higuera C, Lee HH, Krebs VE. Prospective randomized evaluation of the need for blood transfusion during primary total hip arthroplasty with use of a bipolar sealer. J Bone Joint Surg Am. 2011 Mar 16;93(6):513-8. doi: 10.2106/JBJS.J.00036.
  • Kamath AF, Austin DC, Derman PB, Clement RC, Garino JP, Lee GC. Saline-coupled bipolar sealing in simultaneous bilateral total knee arthroplasty. Clin Orthop Surg. 2014 Sep;6(3):298-304. doi: 10.4055/cios.2014.6.3.298. Epub 2014 Aug 5.
  • Abuzakuk T, Senthil Kumar V, Shenava Y, Bulstrode C, Skinner JA, Cannon SR, Briggs TW. Autotransfusion drains in total knee replacement. Are they alternatives to homologous transfusion? Int Orthop. 2007 Apr;31(2):235-9. Epub 2006 Jun 8.
  • Pfeiffer M, Bräutigam H, Draws D, Sigg A. A new bipolar blood sealing system embedded in perioperative strategies vs. a conventional regimen for total knee arthroplasty: results of a matched-pair study. Ger Med Sci. 2005 Dec 13;3:Doc10.
  • Clement RC, Kamath AF, Derman PB, Garino JP, Lee GC. Bipolar sealing in revision total hip arthroplasty for infection: efficacy and cost analysis. J Arthroplasty. 2012 Aug;27(7):1376-81. doi: 10.1016/j.arth.2011.11.016. Epub 2012 Jan 21.
  • Diedo N, Moore G, et al. Effectiveness of the bipolar sealer in reducing blood loss in total knee arthroplasty. International Journal of Orthopaedic and Trauma Nursing (2013) 17, 29-37
  • Suarez JC, Slotkin EM, Szubski CR, Barsoum WK, Patel PD. Prospective, Randomized Trial to Evaluate Efficacy of a Bipolar Sealer in Direct Anterior Approach Total Hip Arthroplasty. J Arthroplasty. 2015 Nov;30(11):1953-8. doi: 10.1016/j.arth.2015.05.023. Epub 2015 May 19.
  • Rosenberg AG. Reducing blood loss in total joint surgery with a saline-coupled bipolar sealing technology. J Arthroplasty. 2007 Jun;22(4 Suppl 1):82-5.
  • Saltzman BM, Oni JK. A Review of Bipolar Sealer Use in Modern Total Joint Arthroplasty. Ann Orthop Rheumatol. 2014 2(2): 1015
  • Marulanda GA, Krebs VE, Bierbaum BE, Goldberg VM, Ries M, Ulrich SD, Seyler TM, Mont MA. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2009 Dec;38(12):E179-83.
  • Lyons ST, Morrison K, Bernasek TL. Sensory neuropathy associated with cauterization using bipolar radio frequency device in primary TKA. Paper presented at: American Academy of Orthopaedic Surgeons Annual Meeting; March 9-13, 2010; New Orleans, LA

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019) 		168
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nancy Dengler, RN, MS 5164962637 ndengler@northwell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952546
Other Study ID Numbers  ICMJE HS16-0236
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Northwell Health
Study Sponsor  ICMJE Northwell Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eugene S. Krauss, MD Northwell Health
PRS Account Northwell Health
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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