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Completed

NCT Number: NCT01583465

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

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.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Arthritis, Rheumatoid Autoimmune Diseases Blood Loss, Surgical Bone Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Developmental Dysplasia of the Hip Hemorrhage Hip Dislocation, Congenital Immune System Diseases Intraoperative Complications Joint Deformities, Acquired Joint Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint Implant Surgeons, Inc.

New Albany, Ohio, 43054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aquamantys

Device

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

standard electrocautery (Bovie)

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Joint Implant Surgeons, Inc.

Other

Collaborators

  • Medtronic
  • Mount Carmel Health System

Registry information

Official study 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)

Acronym: Aquamantys

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 24, 2012
Registry last updated
Apr 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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