Status:
COMPLETED
A Comparison Between Signature Total Knee Arthroplasty (TKA) to Conventional TKA and Computer Assisted TKA
Lead Sponsor:
Zimmer Biomet
Conditions:
Joint Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
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 Arthrop...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01145157
Start Date
July 1 2010
End Date
February 1 2015
Last Update
August 2 2017
Active Locations (1)
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1
Repatriation General Hospital (RGH)
Daw Park, South Australia, Australia, 5041