Bipolar Sealer Aquamantys Use in Total Knee Replacement

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736644
• Other study ID #: TD-07709
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: October 27, 2013

Study information

• Verified date: February 2020
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 27, 2013
• Est. primary completion date: October 27, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Disability
• Hemorrhage
• Infection
• Inflammation
• Osteoarthritis
• Surgery

Intervention

Device:
• Electrocautery
Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery
• Bipolar sealer Aquamantys
Aquamantys use in tourniquet and tourniquetless total knee replacement.

Locations

Country	Name	City	State
United Kingdom	South West London Elective Orthopaedic Center	Epsom	Surrey
United Kingdom	Freeman Hospital	Newcastle upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Surgical Technologies

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

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. — View Citation

Pfeiffer M, Bräutigam 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Loss	The primary outcome will be total blood loss throughout the hospital stay.	upto to 72 hrs after surgery
Secondary	Rehabilitation	Discharge criteria evaluated.	6-weeks