A Comparison Between Signature Personalised Patient Care to Conventional Total Knee Arthroplasty (TKA) and Computer Assisted Navigation
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Purpose
This is a prospective, randomised clinical outcomes study comparing the Signature Personalised Patient Care, Conventional Total Knee Arthroplasty and Computer Assisted Navigation, using Vanguard Knee System. The aim of the study is to evaluate the safety and efficacy of TKA using Signature Personalised Patient Care compared to Conventional TKA and Computer Assisted Navigation.
| Condition | Intervention |
|---|---|
|
Arthroplasty, Replacement, Knee |
Device: Signature Knee Guide Device: Conventional Instrumentation Device: Computer Assisted Navigation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Mechanical Axial Alignment [ Time Frame: Six months post-operative ] [ Designated as safety issue: No ]The primary radiological outcome will be tibial rotation
- Functional outcomes - Knee Society Score [ Time Frame: One year post-operative ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient is of legal age and skeletally mature
- Patient requires primary total knee arthroplasty due to non- inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, a vascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., Rheumatoid arthritis).
- Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, haematological, etc., conditions that would pose excessive operative risk
- The patient will be available for follow up throughout the duration of the study.
Exclusion Criteria:
Patient is unable to have an MRI scan due to the following conditions:
- Cardiac pacemaker
- Surgical clips in head (aneurysm clips)
- Some artificial heart valves
- Electronic inner ear implants
- Metal fragments in eyes
- Electronic stimulators
- Implanted pumps
- Patient has active infection or sepsis (treated or untreated)
- Patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
- Patient is female of child-bearing age and not taking contraceptive precautions.
- Patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia).
- Patient has known moderate to severe renal insufficiency.
- Patient has a known or suspected metal sensitivity.
- Patient is immunosuppressed or receiving high doses of corticosteroids.
- Patient has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, or drug, alcohol abuse.
- Patient has BMI >40.
Contacts and Locations| Australia, South Australia | |
| Repatriation General Hospital (RGH) | Recruiting |
| Daw Park, South Australia, Australia, 5041 | |
| Contact: Nisha Narang 61 8 8275 1683 nisha.narang@health.sa.gov.au | |
| Principal Investigator: Jegan Krishnan | |
| Sub-Investigator: Graham Mercer | |
| Principal Investigator: | Jegan Krishnan | Flinders Medical Centre |
More Information
No publications provided
| Responsible Party: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT01145157 History of Changes |
| Other Study ID Numbers: | BMET AU03 |
| Study First Received: | June 15, 2010 |
| Last Updated: | November 15, 2012 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Biomet, Inc.:
|
knee arthroplasty |
ClinicalTrials.gov processed this record on May 16, 2013