Bipolar Sealer Aquamantys Use in Total Knee Replacement

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Hemorrhage; Arthritis; Osteoarthritis; Surgery; Disability; Infection
• Intervention / Treatment: Device: Electrocautery; Device: Bipolar sealer Aquamantys

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle upon Tyne, United Kingdom
    • Freeman Hospital
  • Surrey
    • Epsom, Surrey, United Kingdom, Kt18 7EG
      • South West London Elective Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss	The primary outcome will be total blood loss throughout the hospital stay.	upto to 72 hrs after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehabilitation	Discharge criteria evaluated.	6-weeks

Collaborators and Investigators

• Sponsor: Medtronic Surgical Technologies
• Investigators: Principal Investigator: Richard E Field, Md, PhD, FRCS, SWLEOC

Publications and helpful links

General Publications

• 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.
• 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.
• Pfeiffer M, Brautigam H, Draws D, Sigg A. A new bipolar blood sealing system embedded in perioperative strategies vs. a conventional regimen for total knee arthroplasty: results of a matched-pair study. Ger Med Sci. 2005 Dec 13;3:Doc10.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2012
• Primary Completion (ACTUAL): October 27, 2013
• Study Completion (ACTUAL): October 27, 2013

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (ESTIMATE): November 29, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: blood loss; total knee replacement; primary total knee arthroplasty; bipolar sealer; aquamantys
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Hemorrhage
• Other Study ID Numbers: TD-07709