This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).
A total of 230 subjects will be randomized (1:1) to receive either an OXINIUM or cobalt chrome femoral components as part of their LEGION revision procedure. The objective of this study is to assess a lower serum metal ion concentration level in at least one of the three major mLTTs (Co, Cr or Ni) over 5 years in subjects receiving OXINIUM versus Cobalt Chrome femoral components as part of the LEGION Revision Total Knee System.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Investigational Group
Control Group
Rothman Institute
Egg Harbor, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Orthopaedic Innovation Centre
Winnipeg, Manitoba, Canada
Major modified Lymphocyte Transformation Tests (Cobalt, Chromium and Nickel) measurements
Metal hypersensitivity will be concluded if at least one of these three measurements is statistically significant
Time frame: 3,650 Days
Minor modified Lymphocyte Transformation Tests (Aluminum, Iron, Molybdenum, Vanadium and Zirconium)
changes in mean mLTTs serum concentration values from baseline to each subsequent assessment
Time frame: 3,650 Days
Changes in mean serum bio-markers from baseline to each subsequent assessment
Time frame: 3,650 Days
Skin lesion evaluation to measure hypersensitivity
Time frame: 3,650 Days
Revision of LEGION Revision Knee System for any reason at each post-surgical assessment
Time frame: 3,650 Days
Improves in mean 2011 Knee Society Score (2011 KSS) from baseline to each subsequent assessment
Time frame: 3,650 Days
Anteroposterior, lateral and skyline knee views are assessed by radiographs
Time frame: 3,650 Days
All adverse event reporting from surgery to 10 year post-surgery
Time frame: 3,650 Days
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