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
1 other identifier
interventional
97
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 20, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2013
CompletedFebruary 27, 2020
February 1, 2020
1.1 years
November 20, 2012
February 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Loss
The primary outcome will be total blood loss throughout the hospital stay.
upto to 72 hrs after surgery
Secondary Outcomes (1)
Rehabilitation
6-weeks
Study Arms (2)
Electrocautery
PLACEBO COMPARATORUse of electrocautery in tourniquet and without tourniquet total knee replacement surgery.
Bipolar Sealer Aquamantys
ACTIVE COMPARATORUse of bipolar sealer Aquamantys in tourniquet and tourniquetless total knee replacement surgical procedures.
Interventions
Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery
Aquamantys use in tourniquet and tourniquetless total knee replacement.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
South West London Elective Orthopaedic Center
Epsom, Surrey, Kt18 7EG, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Related Publications (3)
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.
PMID: 20145794BACKGROUNDMarulanda 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.
PMID: 16525984BACKGROUNDPfeiffer 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.
PMID: 19675727BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard E Field, Md, PhD, FRCS
SWLEOC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2012
First Posted
November 29, 2012
Study Start
October 1, 2012
Primary Completion
October 27, 2013
Study Completion
October 27, 2013
Last Updated
February 27, 2020
Record last verified: 2020-02