prodisc® c total disc replacement - SynthesShare on:
2 DePuy Synthes Spine PRODISC C IDE Clinical Study. CLINICAL STUDy. Study Objective. The study objective was to evaluate the safety and effectiveness of ...
prodisc® c total disc replacement - Synthes
1 DePuy Synthes Spine PRODISC C Total Disc Replacement Patient Guide. Why have I been ... studies, your doctor has decided that you may benefit from ...
ProDisc-C Total Disc Replacement. For single level spinal - Synthes
The ProDisc-C Total Disc Replacement is a modular implant consisting of two .... There were no patients in the pivotal study who were less than 22 years of age.
ProDisc-C and Anterior Cervical Discectomy and Fusion as Surgical
Five-Year Results of a Food and Drug Administration Study. Jack E. Zigler , MD ... cervical total disc replacement (TDR) with ProDisc-C (Synthes. Spine USA ...
Zigler Spine 2013.pdf
ProDisc-C Total Disc Replacement Fact Sheet.
In the United States, an IDE study was initiated in the summer of 2003. The ProDisc-C Total Disc. Replacement was approved by the FDA based on the results of ...
The ProDisc-C Total Disc Replacement System Was Effective for
Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc-C Total Disc Replacement Versus. Anterior Discectomy and ...
PDC TDR Effective for Symptomatic CDD - JBJS Nov2009.pdf
ProDisc-C Total Disc Replacement Versus Anterior Cervical
Nov 4, 2015 ... Clinical outcomes after total disc arthroplasty with ProDisc-C were similar ... patients in the original study were followed at annual intervals until ...
summary of safety and effectiveness data i. general - FDA
Dec 17, 2007 ... The warnings and precautions can be found in the Pro Disc ™-C .... study comparing I 03 patients implanted with the ProDisc™-C Total Disc.
ProDiscTM-C Total Disc Replacement PACKAGE INSERT - FDA
Dec 12, 2007 ... ProDisc-C Implant, extra large Deep 5mm, sterile. 09.820. .... The following adverse events were reported during the clinical study comparing.
single-center results at 7 years of prospective, randomized ProDisc
This study is part of a multicenter US Food and Drug Administration ... Patients were randomized to either TDA using the ProDisc-C device or ACDF.
Total Artificial Disc Replacement for the Spine
Jun 1, 2016 ... studies suggests that potential degeneration of adjacent discs and facets and .... The ProDisc-C Total Disc Replacement is composed of three ...
non-operated adjacent levels, and biomechanical studies have documented .... December 2002. The ProDisc-C cervical disc (Synthes Spine, Paoli, PA).
Effect of arthroplasty design on cervical spine kinematics: analysis of
analysis of the Bryan Disc, ProDisc-C, and Synergy Disc. BRUNO C. R. ... Only single-level arthroplasty cases were included in the study. Lateral dynamic ...
ProDisc Cervical Arthroplasty Does Not Alter Facet Joint Contact
A biomechanical study of facet joint pressure after total disc replacement ... torsion, before and after implantation of a ProDisc-C at that level. Rotations at that ...
Artificial Intervertebral Disc - The Regence Group
element of chance as an explanation of study outcomes, and to allow .... ProDisc- C implant and 106 were treated with fusion; participants were blinded to ...
Comparison of Clinical Outcomes of 1- and 2 - The Spine Institute
Key words: anterior cervical discectomy and fusion , Mobi-C. Cervical Artificial Disc ..... A European study investigating HO rates in Prodisc-C. (Synthes Spine ...
Artificial Intervertebral Disc - BCBSNC.com
disc confirmed by patient history and radiographic studies. ... As with the Prestige ST Cervical Disc, the FDA approval of ProDisc-C is conditional on 7-year ...
The ProDisc-C Prothesis
controlled study, approved by the local ethical committee ... herniation were enrolled and assigned to either study .... Criteria for Patients With ProDisc-C and.
Results of a Prospective Randomized Clinical Trial - Texas Back
ProDisc-C. Key Points. • Longer term follow-up of Level-1 study comparing TDR versus ACDF shows a 5- fold increase in the rate of reoperation for ACDF.
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Apr 8, 2015 ... cervical total disc replacement with ProDisc-C ... The purpose of this study was to evaluate the clinical outcomes after cervical TDR with.