Bipolar Sealer Aquamantys Use in Total Knee Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-27

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.

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Detailed Description

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Conditions

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Osteoarthritis Arthritis Surgery Infection Inflammation Disability Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Electrocautery

Use of electrocautery in tourniquet and without tourniquet total knee replacement surgery.

Group Type PLACEBO_COMPARATOR

Electrocautery

Intervention Type DEVICE

Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery

Bipolar Sealer Aquamantys

Use of bipolar sealer Aquamantys in tourniquet and tourniquetless total knee replacement surgical procedures.

Group Type ACTIVE_COMPARATOR

Bipolar sealer Aquamantys

Intervention Type DEVICE

Aquamantys use in tourniquet and tourniquetless total knee replacement.

Interventions

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Electrocautery

Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery

Intervention Type DEVICE

Bipolar sealer Aquamantys

Aquamantys use in tourniquet and tourniquetless total knee replacement.

Intervention Type DEVICE

Other Intervention Names

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Aquamantys AQM Bipolar sealer

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No