NCT01583465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

April 18, 2012

Last Update Submit

April 23, 2012

Conditions

Osteoarthritis, HipJoint Deformities, AcquiredHip Dislocation, CongenitalOsteonecrosisArthritis, Rheumatoid

Keywords

randomized controlled trialBlood loss, surgicalBlood loss, postoperativeWound healing

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • The development of complications in the wound, either as an inpatient or after discharge

    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

    From admission through hospital discharge (average 2 days, up to 1 week)

Study Arms (2)

Aquamantys Malleable Bipolar Sealer

EXPERIMENTAL

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

Standard Treatment

ACTIVE COMPARATOR

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)

Interventions

AquamantysDEVICE

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.

Also known as: Aquamantys Malleable Bipolar Sealer with Light, 21 CFR 878.4400, Electrosurgery Bipolar Sealer
Aquamantys Malleable 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.

Also known as: electrocautery, Bovie
Standard Treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with pre-existing known coagulopathy
  • Patients on chronic Coumadin (Warfarin) therapy
  • Patients receiving erythropoietin therapy for anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Implant Surgeons, Inc.

New Albany, Ohio, 43054, United States

Location

Related Publications (7)

  • 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.

    PMID: 21411700RESULT

  • 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.

    PMID: 20097039RESULT

  • 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.

    PMID: 21964452RESULT

  • 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.

    PMID: 21082586RESULT

  • 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.

    PMID: 18331175RESULT

  • 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.

    PMID: 16525984RESULT

  • 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.

    PMID: 20145794RESULT

Related Links

MeSH Terms

Conditions

Osteoarthritis, HipJoint Deformities, AcquiredHip Dislocation, CongenitalOsteonecrosisArthritis, RheumatoidBlood Loss, SurgicalPostoperative Hemorrhage

Interventions

Ultraviolet TherapyElectrocoagulation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesDevelopmental Dysplasia of the HipMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesHemorrhageIntraoperative ComplicationsPostoperative Complications

Intervention Hierarchy (Ancestors)

PhototherapyTherapeuticsCauteryAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Keith R Berend, MD

    Joint Implant Surgeons, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 24, 2012

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations

US(1)