Clinical Trial: Efficacy of Aquamantys for Reducing Transfusions With Anterior Supine Intermuscular Approach Total Hip Arthroplasty

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The purpose of this study is to establish whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.

Detailed Summary: To establish in a randomized, blinded study whether or not there is a clinical advantage to the use of Aquamantys® System from Medtronic Advanced Energy (formerly Salient Surgical Technologies) in patients undergoing primary total hip arthroplasty via the anterior supine intermuscular surgical approach in terms of blood loss, transfusion and wound healing based on early collected data. Data will be analyzed using StatsDirect in standard fashion to elucidate any difference between control and treatment groups. Wound healing will be assessed by a blinded observer and based upon a simple and subjective criteria: a) as expected, b) better than expected or c) worse than expected. The blinded observer is experienced in the care of the surgical patient and wound evaluation.
Sponsor: Joint Implant Surgeons, Inc.

Current Primary Outcome:

• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.

Original Secondary Outcome: Same as current

Information By: Joint Implant Surgeons, Inc.

Dates:
Date Received: April 18, 2012
Date Started: October 2009
Date Completion:
Last Updated: April 23, 2012
Last Verified: April 2012