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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
Number of Patients Managed With Blood Transfusion
Time frame: daily during hospital stay (an expected average of 4 days)
Number of Units Transfused
Time frame: daily during hospital stay (an expected average of 4 days)
Estimated Blood Loss
Time frame: Intraoperative (day of surgery)
Change in Hemoglobin Level
Change in hemoglobin level from baseline to the day of hospital discharge.
Time frame: within 30 days before surgery (preop), day of hospital discharge
Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay
Sum of daily morphine-equivalent mg narcotic usage during hospital stay.
Time frame: daily during hospital stay (an expected average of 4 days)
Length of Stay
Time frame: day of hospital discharge
Harris Hip Score (Outcome Score)
A scoring system used to evaluate the outcome after total hip replacement. Domains include pain (44 points), function (47 points), deformity (4 points), and range of motion (5 points). A total score is computed by summing the individual domain scores, with a maximum of 100 points. Higher values represent better outcomes. A total Harris Hip Score below 70 points is generally considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent.
Time frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
Pain Score Scale
A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing "no pain" and 10 representing "unbearable pain." Thus, in this context, lower values represent better outcomes.
Time frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
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