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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Osteoarthritis, Hip, Joint Deformities, Acquired, Hip Dislocation, Congenital, Osteonecrosis, Arthritis, Rheumatoid

Intervention / Treatment
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* Device: Aquamantys
* Device: standard electrocautery (Bovie)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquamantys Malleable Bipolar Sealer<br>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. | Device: Aquamantys<br>* 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.<br>* Other names: Electrosurgery Bipolar Sealer;|
| Active Comparator: Standard Treatment<br>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)<br>* 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.<br>* Other names: Bovie;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Change in Hemoglobin Level | 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. | From up to 30 days preoperative through postoperative day 1 | 
| Perioperative Blood Transfusion Requirement | Perioperative blood transfusion requirements will be recorded, including transfusions administered during the surgical intervention and throughout the acute hospital stay. | From the beginning of surgical intervention to hospital discharge, which averages 2 days and may be up to 1 week postoperative | 
| Perioperative Blood Loss | 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. | From beginning of surgical intervention through hospital discharge, which averages 2 days and may be up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The development of complications in the wound, either as an inpatient or after discharge | 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. | 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 | Length of acute hospital stay will be recorded. | From admission through hospital discharge (average 2 days, up to 1 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized controlled trial, Blood loss, surgical, Blood loss, postoperative, Wound healing