Clinical trial NCT01736644: Bipolar Sealer Aquamantys Use in Total Knee Replacement
Official title: A Prospective Randomized Control Trial to Compare the Aquamantys System With Standard Electrocautery in Reducing Blood Loss in Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Arthritis
Surgery
Infection
Inflammation
Disability
Hemorrhage
Keywords: blood loss
bipolar sealer
aquamantys
total knee replacement
primary total knee arthroplasty
Lead sponsor: Medtronic Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood Loss
timeFrame: upto to 72 hrs after surgery
Secondary outcomes:
measure: Rehabilitation
timeFrame: 6-weeks
Other outcomes:
Locations:
city: Epsom
country: United Kingdom
facility: South West London Elective Orthopaedic Center
state: Surrey
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: SWLEOC
name: Richard E Field, Md, PhD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.