Clinical trial NCT01583465: Efficacy of Aquamantys for Reducing Transfusions With Anterior Supine Intermuscular Approach Total Hip Arthroplasty
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Joint Deformities, Acquired
Hip Dislocation, Congenital
Osteonecrosis
Arthritis, Rheumatoid
Keywords: randomized controlled trial
Blood loss, surgical
Blood loss, postoperative
Wound healing
Lead sponsor: Joint Implant Surgeons, Inc.
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Mount Carmel Health System
First posted: 2012-04-24
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Perioperative Change in Hemoglobin Level
timeFrame: From up to 30 days preoperative through postoperative day 1
measure: Perioperative Blood Transfusion Requirement
timeFrame: From the beginning of surgical intervention to hospital discharge, which averages 2 days and may be up to 1 week postoperative
measure: Perioperative Blood Loss
timeFrame: From beginning of surgical intervention through hospital discharge, which averages 2 days and may be up to 1 week
Secondary outcomes:
measure: The development of complications in the wound, either as an inpatient or after discharge
timeFrame: Wound evaluations will occur each postoperative day in hospital (average 2 days and up to 1 week), at 6 weeks, and 1 year.
measure: Length of stay
timeFrame: From admission through hospital discharge (average 2 days, up to 1 week)
Other outcomes:
Locations:
city: New Albany
country: United States
facility: Joint Implant Surgeons, Inc.
state: Ohio
Study officials:
affiliation: Joint Implant Surgeons, Inc.
name: Keith R Berend, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barsoum WK, Klika AK, Murray TG, Higuera C, Lee HH, Krebs VE. Prospective randomized evaluation of the need for blood transfusion during primary total hip arthroplasty with use of a bipolar sealer. J Bone Joint Surg Am. 2011 Mar 16;93(6):513-8. doi: 10.2106/JBJS.J.00036.
citation: Zeh A, Messer J, Davis J, Vasarhelyi A, Wohlrab D. The Aquamantys system--an alternative to reduce blood loss in primary total hip arthroplasty? J Arthroplasty. 2010 Oct;25(7):1072-7. doi: 10.1016/j.arth.2009.10.008. Epub 2010 Jan 22.
citation: Mankin KP, Moore CA, Miller LE, Block JE. Hemostasis with a bipolar sealer during surgical correction of adolescent idiopathic scoliosis. J Spinal Disord Tech. 2012 Jul;25(5):259-63. doi: 10.1097/BSD.0b013e3182334ec5.
citation: Morris MJ, Berend KR, Lombardi AV Jr. Hemostasis in anterior supine intermuscular total hip arthroplasty: pilot study comparing standard electrocautery and a bipolar sealer. Surg Technol Int. 2010 Oct;20:352-6.
citation: Marulanda GA, Ulrich SD, Seyler TM, Delanois RE, Mont MA. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices. 2008 Mar;5(2):125-31. doi: 10.1586/17434440.5.2.125.
citation: Marulanda GA, Ragland PS, Seyler TM, Mont MA. Reductions in blood loss with use of a bipolar sealer for hemostasis in primary total knee arthroplasty. Surg Technol Int. 2005;14:281-6.
citation: Marulanda GA, Krebs VE, Bierbaum BE, Goldberg VM, Ries M, Ulrich SD, Seyler TM, Mont MA. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2009 Dec;38(12):E179-83.