Efficacy of Aquamantys for Reducing Transfusions With Anterior Supine Intermuscular Approach Total Hip Arthroplasty (Aquamantys)
|ClinicalTrials.gov Identifier: NCT01583465|
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : April 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Hip Joint Deformities, Acquired Hip Dislocation, Congenital Osteonecrosis Arthritis, Rheumatoid||Device: Aquamantys Device: standard electrocautery (Bovie)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Open Label, Randomized, Blinded Study to Evaluate the Efficacy of Aquamantys System for Reducing the Transfusion Requirements Associated With the Anterior-Supine Intermuscular (ASI) Approach for Total Hip Arthroplasty (THA)|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Experimental: Aquamantys Malleable Bipolar Sealer
In 100 patients randomly assigned, primary total hip arthroplasty via an anterior supine intermuscular approach will be performed with the assistance of the Aquamantys Malleable Bipolar Sealer with Light.
Primary THA via the ASI approach will be performed using the Aquamantys Malleable Bipolar Sealer. The Aquamantys is a bipolar device that combines radio-frequency energy and saline to gently reach targeted tissue and provide a biomechanical seal. The saline acts as a conduit to allow the energy to penetrate the tissue from 1 to 2 mm where the collagen is transformed thus providing the seal. The saline also helps cool the tissue which allows for gentle handling of tissue, eliminating the black char that is a port for infection. The surgeon uses the Aquamantys to assist in tissue dissection, cauterize vessels, and to pre-treat fat pad in front of capsule prior to excision, to treat the entire anterior hip capsule prior to excision, treat oozing bone surfaces not covered by an implant.
Active Comparator: Standard Treatment
100 patients randomly assigned will undergo primary total hip arthroplasty via the anterior supine intermuscular approach performed with the assistance of standard electrocautery.
Device: standard electrocautery (Bovie)
Primary total hip arthroplasty via an anterior supine intermuscular approach will be performed with the assistance of standard electrocautery. The electrocautery is used in tissue dissection and to cauterize bleeding vessels.
- Perioperative Change in Hemoglobin Level [ Time Frame: From up to 30 days preoperative through postoperative day 1 ]All patients will undergo routine lab work perioperatively. No additional studies will be necessary for this protocol. Hemoglobin level will be first measured preoperatively at the time of preadmission testing, which must be performed not more than 30 days prior to surgery, and then measured on postoperative day one. The two levels will be compared to assess the decrease in hemoglobin level resulting from the surgical intervention.
- Perioperative Blood Transfusion Requirement [ Time Frame: From the beginning of surgical intervention to hospital discharge, which averages 2 days and may be up to 1 week postoperative ]Perioperative blood transfusion requirements will be recorded, including transfusions administered during the surgical intervention and throughout the acute hospital stay.
- Perioperative Blood Loss [ Time Frame: From beginning of surgical intervention through hospital discharge, which averages 2 days and may be up to 1 week ]Anesthesia and nursing records will be monitored for blood loss intraoperatively, and postoperatively via drain output. Drains will be pulled daily at 0600 and measured.
- The development of complications in the wound, either as an inpatient or after discharge [ Time Frame: Wound evaluations will occur each postoperative day in hospital (average 2 days and up to 1 week), at 6 weeks, and 1 year. ]Wound care will be evaluated by a designee who will be blinded to the randomization. Wound will be evaluated for drainage, erythema, and ecchymosis. Additionally, the wound healing will be scored as: Healing better than expected, As expected, or Worse than expected. Wound evaluations will occur each postoperative day in hospital (average 2 days), at 6 weeks, and 1 year.
- Length of stay [ Time Frame: From admission through hospital discharge (average 2 days, up to 1 week) ]Length of acute hospital stay will be recorded.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583465
|United States, Ohio|
|Joint Implant Surgeons, Inc.|
|New Albany, Ohio, United States, 43054|
|Principal Investigator:||Keith R Berend, MD||Joint Implant Surgeons, Inc.|