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Bipolar Sealer Aquamantys Use in Total Knee Replacement

This study is currently recruiting participants.
Verified November 2012 by Medtronic Surgical Technologies
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies
ClinicalTrials.gov Identifier:
NCT01736644
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

This study will compare the clinical outcomes for patients undergoing a total knee replacement using a bipolar sealer, the Aquamantys® System, as compared to standard electrocautery. Total blood loss during the hospital stay and knee mobility and discharge factors will be analyzed.


Condition Intervention Phase
Osteoarthritis
Arthritis
Surgery
Infection
Inflammation
Disability
Hemorrhage
 Device: Electrocautery
Device: Bipolar sealer Aquamantys
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Control Trial to Compare the Aquamantys System With Standard Electrocautery in Reducing Blood Loss in Primary Total Knee Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Surgical Technologies:

Primary Outcome Measures:
  • Blood Loss [ Time Frame: upto to 72 hrs after surgery ] [ Designated as safety issue: No ]
    The primary outcome will be total blood loss throughout the hospital stay.


Secondary Outcome Measures:
  • Rehabilitation [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
    Discharge criteria evaluated.


Estimated Enrollment: 112
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Electrocautery
Use of electrocautery in tourniquet and without tourniquet total knee replacement surgery.
 Device: Electrocautery
Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery
Active Comparator: Bipolar Sealer Aquamantys
Use of bipolar sealer Aquamantys in tourniquet and tourniquetless total knee replacement surgical procedures.
 Device: Bipolar sealer Aquamantys
Aquamantys use in tourniquet and tourniquetless total knee replacement.
Other Names:
  • Aquamantys
  • AQM
  • Bipolar sealer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is ≥18 years of age
  • Patient has failed conservative therapy of osteoarthritis of the knee and has been listed to undergo primary TKA
  • Patient is willing and able to provide written informed consent.
  • Pre-assessment Haemoglobin ≥ 11.0g/dl
  • Patient is suitable to receive spinal anaesthesia with no peripheral nerve blocks
  • Patients willing to undergo blood transfusion

Exclusion Criteria:

  • Patients that are listed for unicondylar or revision TKA
  • Patients who are being converted from a previous high tibial osteotomy and a previous unicondylar knee arthroplasty
  • Fixed motor deficit thus affecting functional assessment of the knee
  • Patients presenting with a non-osteoarthritis degenerative knee diagnosis
  • Patients presenting with known contralateral knee osteoarthritis requiring simultaneous bilateral TKA
  • Patients presenting with a history of previous knee infection
  • Patients presenting with a pre-operative knee range of motion < 85°
  • Knee deformity greater than 20 degrees varus or valgus
  • Patients presenting with a history of bleeding disorders and/or are on chronic blood anticoagulation therapy
  • Patients with significantly impaired renal function (defined by EGFR >30)
  • Patients with allergy or sensitivity to non-steroidal anti-inflammatory drugs, ropivacaine, ketoprofen or adrenaline
  • Patients presenting with an internal cardiac defibrillator
  • Women who are pregnant
  • Evidence of active (systemic or local) infection at time of surgery
  • Patients who have habitual opioid use
  • Patients who have a psychiatric or mental illness which could impair the consent process or ability to complete patient-report questionnaires
  • Morbid obesity [BMI > 40]
  • Patients who are unwilling to undergo blood transfusion, if necessary
  • Patients who are receiving any implant used in conjunction with a customised-cutting block system
  • Any patient who cannot or will not provide written informed consent for participation in the study
  • Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736644

Locations
United Kingdom
South West London Elective Orthopaedic Center Recruiting
Epsom, Surrey, United Kingdom, Kt18 7EG
Contact: Jocelyn Buly     011441372735425     jocelyn.buly@eoc.nhs.uk    
Contact: Jas Curtis     011441372735425     jas.curtis@eoc.nhs.uk    
Principal Investigator: Richard Field, MD, PHD,FRCS            
Sponsors and Collaborators
Medtronic Surgical Technologies
Investigators
Principal Investigator: Richard E Field, Md, PhD, FRCS SWLEOC
  More Information

Publications:

Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT01736644     History of Changes
Other Study ID Numbers: TD-07709
Study First Received: November 20, 2012
Last Updated: November 26, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Medtronic Surgical Technologies:
blood loss
bipolar sealer
aquamantys
total knee replacement
primary total knee arthroplasty

Additional relevant MeSH terms:
Arthritis
Hemorrhage
Inflammation
Osteoarthritis
 Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013