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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WITHDRAWN
NA
INTERVENTIONAL
2016-01-31
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LEGION OXINIUM femoral component
LEGION OXINIUM
Investigational Group
LEGION Cobalt Chrome femoral components
LEGION Cobalt Chrome
Control Group
Interventions
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LEGION OXINIUM
Investigational Group
LEGION Cobalt Chrome
Control Group
Eligibility Criteria
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Inclusion Criteria
* Subject is willing to sign and date an IRB/EC approved consent form
* Subject is a candidate for a revision knee replacement
* Subject has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk
* Subject agrees to adhere to the 10-year study visit schedule
Exclusion Criteria
* Subject requires a known bilateral revision TKA
* Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation
* Subject has active infection or sepsis (treated or untreated)
* Subject with an immunosuppressive disorder
* Subject has presence of malignant tumor, metastatic, or neoplastic disease
* Subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
* Subject has had intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
* Subject has inadequate bone stock to support the device and would require significant augmentation to correct the joint Female subject is of child-bearing age and unwilling to use an approved method of contraception
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to comply with the study
* Subject is severely overweight (BMI\>40)
* Subject is currently enrolled in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days
* Subject is facing current or impending incarceration
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Turgeon, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Innovation Centre
Locations
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Rothman Institute
Egg Harbor, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Orthopaedic Innovation Centre
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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13-4050-05
Identifier Type: -
Identifier Source: org_study_id
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