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ISASS: Kineflex-L and Charite lumbar discs provide significant clinical improvement in TDR

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Ace Report Cover
April 2013

ISASS: Kineflex-L and Charite lumbar discs provide significant clinical improvement in TDR

Vol: 2| Issue: 3| Number:98| ISSN#: 2564-2537
Study Type:Randomized Trial
OE Level Evidence:N/A
Journal Level of Evidence:N/A

Five-year follow-up of a prospective, randomized FDA IDE trial comparing two lumbar total disc replacements: clinical outcome and serum ion level analysis for a metal-on-metal device

Contributing Authors:
RD Guyer K Pettine T Dimmig D Coric A Cappuccino J Roh

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CONFERENCE ACE REPORTS

This ACE Report is a summary of a conference presentation or abstract. The information provided has limited the ability to provide an accurate assessment of the risk of bias or the overall quality. Please interpret the results with caution as trials may be in progress and select results may have been presented.

Synopsis

394 patients undergoing total disc replacement were randomized to receive either the Kineflex-L or Charite artificial lumbar disc in order to determine if there were any differences in outcomes attained by either device. Patients were followed-up for 5 years assessing clinical outcomes, disability, pain, and rate of re-operation or revision surgery. Also, a subsample of patients were analyzed for...

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