NCT01027195

Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Arthritis

Interventions

Type	Name	Description
DEVICE	Bipolar Radiofrequency (Aquamantys 6.0)
DEVICE	Standard Bovie Electrocautery

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-04-01
• Completion: 2009-06-01
• First posted: 2009-12-07
• Last updated: 2012-11-29
• Results posted: 2012-11-29