A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA
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|ClinicalTrials.gov Identifier: NCT01145157|
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : August 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Joint Disease||Device: Signature Knee Guide Device: Conventional Instrumentation Device: Computer Assisted Navigation||Not Applicable|
The objective of this study is to report and compare on the outcomes from patients undergoing total knee arthroplasty utilizing 'SignatureTM Personalised Patient Care', Conventional Total Knee Arthroplasty and Computer Assisted Navigation.
The 'SignatureTM Personalised Patient Care' is a system that uses a patient's Magnetic Resonance Imaging (MRI) and X-ray design to build surgical instruments customized for a patient's unique knee anatomy. Cutting positioning guides are produced to match the outer shape of the individual's distal femur and proximal tibia.
The cutting positioning guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison Between 'Signature™ Personalised Patient Care' to Conventional Total Knee Arthroplasty and Computer Assisted Navigation and a Cost Benefit Analysis for the Australian Market|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||February 2015|
Experimental: Signature Knee Guide
Total Knee Arthroplasty using the Signature Knee Guide with the Vanguard Knee System
Device: Signature Knee Guide
Total Knee Arthroplasty performed using Signature Knee Guide
Active Comparator: Conventional Instrumentation
Total Knee Arthroplasty will be performed using Conventional Instrumentation with the Vanguard Knee System
Device: Conventional Instrumentation
Total Knee Arthroplasty performed using Conventional Instrumentation
Active Comparator: Computer Assisted Navigation
Total Knee Arthroplasty will be performed using Computer Assisted Navigation with the Vanguard Knee System
Device: Computer Assisted Navigation
Total Knee Arthroplasty performed using Computer Assisted Navigation
- Mechanical Axial Alignment [ Time Frame: Six months post-operative ]The primary radiological outcome will be tibial rotation
- Functional outcomes - Knee Society Score [ Time Frame: One year post-operative ]The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145157
|Australia, South Australia|
|Repatriation General Hospital (RGH)|
|Daw Park, South Australia, Australia, 5041|
|Principal Investigator:||Jegan Krishnan||Flinders Medical Centre|