Bipolar Sealer Aquamantys Use in Total Knee Replacement

Not Applicable

Completed

• Conditions: Disability; Hemorrhage; Osteoarthritis; Surgery; Arthritis; Infection; Inflammation

• Registration Number: NCT01736644
• Lead Sponsor: Medtronic Surgical Technologies

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Primary Completion: 2013-10-27
• Study Completion: 2013-10-27
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Blood Loss	upto to 72 hrs after surgery	The primary outcome will be total blood loss throughout the hospital stay.

Secondary Outcome Measures

Name	Time	Method
Rehabilitation	6-weeks	Discharge criteria evaluated.

Trial Locations

Locations (2)

South West London Elective Orthopaedic Center; 🇬🇧 Epsom, Surrey, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle upon Tyne, United Kingdom