Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty (Hip)
|ClinicalTrials.gov Identifier: NCT01027195|
Recruitment Status : Completed
First Posted : December 7, 2009
Results First Posted : November 29, 2012
Last Update Posted : November 29, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hip Arthritis||Device: Bipolar Radiofrequency (Aquamantys 6.0) Device: Standard Bovie Electrocautery||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Evaluation of the Efficacy of the Bipolar Sealer Aquamantys 6.0 in Patients Undergoing Total Hip Arthroplasty|
|Study Start Date :||August 2006|
|Primary Completion Date :||April 2009|
|Study Completion Date :||June 2009|
Placebo Comparator: Standard Bovie Electrocautery
Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
|Device: Standard Bovie Electrocautery|
Experimental: Bipolar Radiofrequency
Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
Device: Bipolar Radiofrequency (Aquamantys 6.0)
Other Name: Aquamantys 6.0
- 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 [ Time Frame: within 30 days before surgery (preop), day of hospital discharge ]Change in hemoglobin level from baseline to the day of hospital discharge.
- Total Narcotic Usage (Morphine-equivalent mg) During Hospital Stay [ Time Frame: daily during hospital stay (an expected average of 4 days) ]Sum of daily morphine-equivalent mg narcotic usage during hospital stay.
- Length of Stay [ Time Frame: day of hospital discharge ]
- Harris Hip Score (Outcome Score) [ 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.
- Pain Score Scale [ 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027195
|Principal Investigator:||Wael K Barsoum, MD||The Cleveland Clinic|