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Bipolar Sealer Aquamantys Use in Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT01736644
Recruitment Status : Unknown
Verified February 2014 by Medtronic Surgical Technologies.
Recruitment status was:  Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis Arthritis Surgery Infection Inflammation Disability Hemorrhage Device: Electrocautery Device: Bipolar sealer Aquamantys Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
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
Study Start Date : October 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Blood Loss [ Time Frame: upto to 72 hrs after surgery ]
    The primary outcome will be total blood loss throughout the hospital stay.


Secondary Outcome Measures :
  1. Rehabilitation [ Time Frame: 6-weeks ]
    Discharge criteria evaluated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736644


Locations
United Kingdom
South West London Elective Orthopaedic Center
Epsom, Surrey, United Kingdom, Kt18 7EG
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Sponsors and Collaborators
Medtronic Surgical Technologies
Investigators
Principal Investigator: Richard E Field, Md, PhD, FRCS SWLEOC

Publications:
Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT01736644     History of Changes
Other Study ID Numbers: TD-07709
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: February 2014

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

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