Bipolar Sealer Aquamantys Use in Total Knee Replacement

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medtronic Surgical Technologies Identifier:
First received: November 20, 2012
Last updated: February 3, 2014
Last verified: February 2014

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
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:

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 2014
Estimated Primary Completion Date: June 2014 (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


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

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 identifier: NCT01736644

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
Principal Investigator: Richard E Field, Md, PhD, FRCS SWLEOC
  More Information

Responsible Party: Medtronic Surgical Technologies Identifier: NCT01736644     History of Changes
Other Study ID Numbers: TD-07709
Study First Received: November 20, 2012
Last Updated: February 3, 2014
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases processed this record on April 21, 2014