Skip to main content
OpenTrials
Completed

NCT Number: NCT01736644

Bipolar Sealer Aquamantys Use in Total Knee Replacement

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South West London Elective Orthopaedic Center, Epsom, Surrey, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrocautery

Device

Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery

Bipolar sealer Aquamantys

Device

Aquamantys use in tourniquet and tourniquetless total knee replacement.

Other names: Aquamantys, AQM, Bipolar sealer

Primary outcomes

  1. Blood Loss

    Time frame: upto to 72 hrs after surgery

    The primary outcome will be total blood loss throughout the hospital stay.

Secondary outcomes

  1. Rehabilitation

    Time frame: 6-weeks

    Discharge criteria evaluated.

Sponsors and collaborators

Lead sponsor

Medtronic Surgical Technologies

Industry

Registry information

Official study title

A Prospective Randomized Control Trial to Compare the Aquamantys System With Standard Electrocautery in Reducing Blood Loss in Primary Total Knee Arthroplasty

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2012
Registry last updated
Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.