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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Joint Implant Surgeons, Inc.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Perioperative Change in Hemoglobin Level
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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 Description
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.
Investigators
Keith R. Berend
Principal Investigator
Joint Implant Surgeons, Inc.
Eligibility Criteria
Inclusion Criteria
- •Undergoing primary unilateral total hip arthroplasty via the anterior supine intermuscular approach
- •Patient is willing and able to complete all follow-up visits at 6 weeks and 1 year
Exclusion Criteria
- •Patients with pre-existing known coagulopathy
- •Patients on chronic Coumadin (Warfarin) therapy
- •Patients receiving erythropoietin therapy for anemia
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The development of complications in the wound, either as an inpatient or after discharge(Wound evaluations will occur each postoperative day in hospital (average 2 days and up to 1 week), at 6 weeks, and 1 year.)
- Length of stay(From admission through hospital discharge (average 2 days, up to 1 week))