A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA
NCT ID: NCT01145157
Last Updated: 2017-08-02
Study Results
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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COMPLETED
NA
150 participants
INTERVENTIONAL
2010-07-31
2015-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Signature Knee Guide
Total Knee Arthroplasty using the Signature Knee Guide with the Vanguard Knee System
Signature Knee Guide
Total Knee Arthroplasty performed using Signature Knee Guide
Conventional Instrumentation
Total Knee Arthroplasty will be performed using Conventional Instrumentation with the Vanguard Knee System
Conventional Instrumentation
Total Knee Arthroplasty performed using Conventional Instrumentation
Computer Assisted Navigation
Total Knee Arthroplasty will be performed using Computer Assisted Navigation with the Vanguard Knee System
Computer Assisted Navigation
Total Knee Arthroplasty performed using Computer Assisted Navigation
Interventions
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Signature Knee Guide
Total Knee Arthroplasty performed using Signature Knee Guide
Conventional Instrumentation
Total Knee Arthroplasty performed using Conventional Instrumentation
Computer Assisted Navigation
Total Knee Arthroplasty performed using Computer Assisted Navigation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Jegan Krishnan
Role: PRINCIPAL_INVESTIGATOR
Flinders Medical Centre
Locations
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Repatriation General Hospital (RGH)
Daw Park, South Australia, Australia
Countries
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References
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Cundy WJ, Theodoulou A, Ling CM, Krishnan J, Wilson CJ. Blood Loss in Total Knee Arthroplasty. J Knee Surg. 2017 Jun;30(5):452-459. doi: 10.1055/s-0036-1592147. Epub 2016 Sep 21.
Other Identifiers
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BMET AU03 (INT.CR.LAU3)
Identifier Type: -
Identifier Source: org_study_id
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