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

Medtronic Surgical Technologies2 sites in 1 country97 target enrollmentOctober 2012

ConditionsOsteoarthritis Arthritis Surgery Infection Inflammation Disability Hemorrhage

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Medtronic Surgical Technologies
Enrollment: 97
Locations: 2
Primary Endpoint: Blood Loss
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

October 27, 2013

Last Updated

6 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Medtronic Surgical Technologies

Responsible Party

Sponsor

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)