Bipolar Sealer Aquamantys Use in Total Knee Replacement

Medtronic

Status

Completed

Conditions

Disability

Inflammation

Infection

Hemorrhage

Osteoarthritis

Arthritis

Surgery

Treatments

Device: Bipolar sealer Aquamantys

Device: Electrocautery

Study type

Interventional

Funder types

Industry

Identifiers

NCT01736644

TD-07709

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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