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

April 23, 2012 updated by: Keith R. Berend, Joint Implant Surgeons, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • New Albany, Ohio, United States, 43054
        • Joint Implant Surgeons, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Aquamantys
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.
Other Names:
  • Aquamantys Malleable Bipolar Sealer with Light
  • 21 CFR 878.4400
  • Electrosurgery Bipolar Sealer
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.
Other Names:
  • Bovie
  • electrocautery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From up to 30 days preoperative through postoperative day 1
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.
From the beginning of surgical intervention to hospital discharge, which averages 2 days and may be up to 1 week postoperative
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.
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
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.
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
Time Frame: From admission through hospital discharge (average 2 days, up to 1 week)
Length of acute hospital stay will be recorded.
From admission through hospital discharge (average 2 days, up to 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joint Implant Surgeons, Inc.

Collaborators

Medtronic
Mount Carmel Health System

Investigators

  • Principal Investigator: Keith R Berend, MD, Joint Implant Surgeons, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Estimate)

April 24, 2012

Last Update Submitted That Met QC Criteria

April 23, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20091312

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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