Osteoarthritis of the Knee Clinical Trial
Official title:
PATIENT-MATCHED INSTRUMENTATION Versus (vs) STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION
- Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL
TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION
- Short Title: Visionaire Alignment
- Methodology: Monocentric, Single Blinded, Randomized Controlled Trial
- Study Duration: November 2010 to July 2014
- Study Centres: Leicester General Hospital, United Kingdom (UK)
Malalignment is one of the main reasons for knee arthroplasty revision. With the use of
patient matched cutting block we expect better axial alignment of the components.
Research Objectives:
- The primary research objective is to evaluate the axial alignment and component position
in TKA with use of Smith & Nephew's VISIONAIRE Patient Matched Technology and to compare
with the alignment when standard instrumentation.
- Secondary research objectives include assessing the safety and effectiveness of the
VISIONAIRE patient matched technology as compared to commonly accepted standard
instrumentation in patients suffering from symptomatic osteoarthritis of the knee joint.
- Outcome Measures:
- Implant alignment and Component position by means of CT-scans
- Knee Society Score
- EuroQol-5 Dimensions (EQ-5D)
- Knee injury and Osteoarthritis Outcome Score (KOOS)
- Oxford Knee Score
- Knee-related adverse events
- Standard and full leg x-ray
- Number of Subjects: 70 (2*35)
- Enrollment time: 18 months
- Diagnosis and Main Inclusion Criteria: Patients with osteoarthritis of the knee
requiring total knee arthroplasty
- Study Product, Dose, Route, Regimen:
VISIONAIRE patient matched technology versus the commonly accepted standard instrumentation
for the Genesis II total knee arthroplasty implant
;
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