Document Detail

An In Vitro Assessment of Wear Particulate Generated from NUBAC, A PEEK on PEEK Articulating Nucleus Replacement Device. Methodology and Results from a Series of Wear Tests Using Different Motion Profiles, Test Frequencies and Environmental Conditions.
MedLine Citation:
PMID:  21494194     Owner:  NLM     Status:  Publisher    
Study Design: In vitro biotribological wear particulate investigation.Objective: To characterize PEEK-OPTIMA wear particulate generated from a series of wear tests used to evaluate the wear resistance and long term biodurability of NUBAC, a PEEK on PEEK articulating nucleus replacement device and compare with wear particulate associated with hip and knee total joint arthroplasties.Summary of Background Data: The use of PEEK in spinal arthroplasty represents a unique application of this material. Clinically, osteolysis, osteolytic changes and adverse reactions to metal ions have been documented in spinal arthroplasty. Therefore, it is critically important to analyze the PEEK wear particulate to evaluate its resultant biologic reactivity. Historically SEM has been used for wear debris characterization. Light scattering, specifically laser diffraction, has also been successfully used. The combined use of both techniques may provide a more comprehensive analysis than either method alone.Methods: Proteinacious serum containing PEEK wear debris generated from four groups of devices from separate wear tests underwent enzymatic and acid digestion. The particulate was analyzed using laser diffraction in duplicate, followed by SEM analysis.Results: Laser diffraction analysis demonstrated a relatively large mean particle diameter based upon particle volume (16.5 to 40.0 μm) as compared to particle number (0.9 to 2.2 μm). For all groups, greater than 50% of debris was larger than 5.0 μm. SEM analysis revealed a mean particle size consistent with the number based laser diffraction results. The morphology of the wear particulate appeared to be similar for all the groups analyzed.Conclusions: The analysis of the particles generated from an articulating PEEK on PEEK nucleus replacement device shows debris within size ranges typical of other total joint arthroplasty implants, with relatively round morphology, along with the results suggesting a reduced particle load. These attributes tend to diminish the potential of these PEEK particles to elicit an inflammatory response.
Tim Brown; Qi-Bin Bao; C Mauli Agrawal; Nadim James Hallab
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-4-7
Journal Detail:
Title:  Spine     Volume:  -     ISSN:  1528-1159     ISO Abbreviation:  -     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-4-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7610646     Medline TA:  Spine (Phila Pa 1976)     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Author affiliations: *Pioneer Surgical Technology, Marquette, MI; **University of Texas at San Antonio, San Antonio, TX; † Rush University Medical Center, Chicago, IL.
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