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

This study has been completed.
Sponsor:
Collaborators:
Medtronic
Mount Carmel Health System
Information provided by (Responsible Party):
Keith R. Berend, Joint Implant Surgeons, Inc.
ClinicalTrials.gov Identifier:
NCT01583465
First received: April 18, 2012
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Osteoarthritis, Hip
Joint Deformities, Acquired
Hip Dislocation, Congenital
Osteonecrosis
Arthritis, Rheumatoid
Device: Aquamantys
Device: standard electrocautery (Bovie)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Joint Implant Surgeons, Inc.:

Primary Outcome Measures:
  • Perioperative Change in Hemoglobin Level [ Time Frame: From up to 30 days preoperative through postoperative day 1 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    Length of acute hospital stay will be recorded.


Enrollment: 200
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • electrocautery
  • Bovie

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583465

Locations
United States, Ohio
Joint Implant Surgeons, Inc.
New Albany, Ohio, United States, 43054
Sponsors and Collaborators
Joint Implant Surgeons, Inc.
Medtronic
Mount Carmel Health System
Investigators
Principal Investigator: Keith R Berend, MD Joint Implant Surgeons, Inc.
  More Information

Additional Information:
Publications:

Responsible Party: Keith R. Berend, Principal Investigator, Joint Implant Surgeons, Inc.
ClinicalTrials.gov Identifier: NCT01583465     History of Changes
Other Study ID Numbers: 20091312
Study First Received: April 18, 2012
Last Updated: April 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Joint Implant Surgeons, Inc.:
randomized controlled trial
Blood loss, surgical
Blood loss, postoperative
Wound healing

Additional relevant MeSH terms:
Congenital Abnormalities
Arthritis
Arthritis, Rheumatoid
Dislocations
Hip Dislocation
Hip Dislocation, Congenital
Osteoarthritis
Osteoarthritis, Hip
Osteonecrosis
Joint Deformities, Acquired
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Bone Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014