Bipolar Sealer Aquamantys Use in Total Knee Replacement

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Arthritis, Surgery, Infection, Inflammation, Disability, Hemorrhage

Intervention / Treatment
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* Device: Electrocautery
* Device: Bipolar sealer Aquamantys


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Electrocautery<br>Use of electrocautery in tourniquet and without tourniquet total knee replacement surgery. | Device: Electrocautery<br>* Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery<br>|
| Active Comparator: Bipolar Sealer Aquamantys<br>Use of bipolar sealer Aquamantys in tourniquet and tourniquetless total knee replacement surgical procedures. | Device: Bipolar sealer Aquamantys<br>* Aquamantys use in tourniquet and tourniquetless total knee replacement.<br>* Other names: Bipolar sealer;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood loss, bipolar sealer, aquamantys, total knee replacement, primary total knee arthroplasty