Bipolar Radiofrequency (Aquamantys 6.0)
DeviceOther names: Aquamantys 6.0
NCT Number: NCT01027195
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Aquamantys 6.0
Time frame: daily during hospital stay (an expected average of 4 days)
Time frame: daily during hospital stay (an expected average of 4 days)
Time frame: Intraoperative (day of surgery)
Time frame: within 30 days before surgery (preop), day of hospital discharge
Change in hemoglobin level from baseline to the day of hospital discharge.
Time frame: daily during hospital stay (an expected average of 4 days)
Sum of daily morphine-equivalent mg narcotic usage during hospital stay.
Time frame: day of hospital discharge
Time frame: within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery
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
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.
The Cleveland Clinic
Other
Acronym: Hip
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