Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty
Condition: Hip Arthritis
MeSH terms: Arthritis
Intervention: Bipolar Radiofrequency (Aquamantys 6.0); Standard Bovie Electrocautery
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The present prospective, single-center, clinical trial is designed to evaluate the hemostatic
      efficacy of the hemostatic sealer Aquamantys 6.0™ in patients managed with total hip
      arthroplasty (THA). It is hypothesized that Aquamantys 6.0™ can improve hemostasis following
      total hip arthroplasty. Comparison of the functional and clinical results between THA
      patients having been exposed to Aquamantys 6.0™ versus a control group will be analyzed using
      several outcome measures including the Harris Hip Score and a pain scale. The primary
      variable of interest is transfusion requirements - specifically, number of patients managed
      with blood transfusion during the hospital stay after surgery. However, of secondary interest
      will be: 1) number of units transfused, 2) estimated intraoperative total blood loss, 3)
      change in pre- and post-operative hemoglobin levels, 4) total narcotic usage during hospital
      stay, 5) length of stay, 6) functional and pain outcomes (Harris Hip Score and Pain Scale),
      and 7) adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 18 - 85 years

          -  Sex: Both male and female will be included. The male-to-female ratio will depend upon
             the patient population.

          -  Stable Health: At the time of surgery based on physical examination and medical
             history.

          -  Patient exhibited preoperative radiographic evidence of joint degeneration consistent
             with THA that could not have been treated in non-operative fashion.

          -  Patient had severe hip pain and disability due to degenerative joint disease.

          -  Patient or patient's legal representative has signed the Informed Consent form. The
             patient is capable of making informed decisions regarding his/her healthcare.

        Exclusion Criteria:

          -  Patients with history of cardiac disease, liver disease or renal disease. Severe
             cardiac disease, liver disease and renal dysfunction can confound different parameters
             within this study. Patients with decreased cardiac function from prior myocardial
             infarction, cardiomyopathy or congestive heart failure will likely require
             transfusions with packed red blood cells at lower thresholds relative to healthy
             counterparts for cardioprotection. Therefore, patients with a prior history of
             myocardial infarction, cardiomyopathy, congestive heart failure or other significant
             cardiac history will be excluded from this study. In addition, patients with liver
             dysfunction from cirrhosis or hepatitis may have impaired production of factors in the
             clotting cascade which may make these individuals more prone to bleed, especially with
             the use of anticoagulants such as lovenox. For this reason, these patients will also
             be excluded from this study. Finally, individuals with renal dysfunction will have
             decreased creatinine clearance, which may artificially elevate the levels of lovenox,
             thereby promoting bleeding. In addition, individuals with severe renal disease may
             also have associated anemia which would complicate the transfusion threshold. For this
             reason, individuals with chronic renal failure, diabetic nephropathy, or decreased
             creatinine clearance will be excluded from this study.

          -  Patients predonating autologous blood.

          -  Patients with preoperative hemoglobin level less than 11.5 g/dL or a hematocrit less
             than 35%. Patients with a preoperative platelet count of less than 100,000.

          -  Patients undergoing bilateral or revision surgery.

          -  Evidence of bleeding or metabolic - based hemolytic disorder (hemophilia or
             anticoagulation use)

          -  Previous history of infection in the affected joint.

          -  Peripheral vascular disease.

          -  Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or
             mental handicap, etc.

          -  Patients whose personal beliefs exclude the use of blood transfusions (example:
             Jehovah's witness).