Five-Year Follow-Up of a Prospective, Randomized Trial Comparing Two Lumbar Total Disc Replacements

Spine
Richard D GuyerDonna D Ohnmeiss

Abstract

This was a prospective, randomized, controlled, multicenter study. The purpose of this study was to compare outcomes of two lumbar total disc replacements (TDRs) at 5-year follow-up and report results of serum ion level analysis in a subgroup of patients receiving a metal-on-metal implant. Lumbar TDR has been compared with fusion in several randomized studies, finding TDR noninferior to fusion and superior on some measures. Receiving less attention has been comparing TDR devices. Additionally, there is concern about metal-on-metal implants, with little data available for spine devices. The study included 204 patients receiving Kineflex-L (investigational) and 190 receiving CHARITÉ (control). Outcome measure included Oswestry Disability Index, visual analog pain scales (VAS), patient satisfaction, neurological status, complications, reoperations, and a composite success score. Radiographic assessment included range of motion, subsidence, and heterotrophic ossification. In 32 investigational patients, serum ion analysis was performed for cobalt and chromium. These values were compared with Medicines and Healthcare Products Regulatory Agency values to merit monitoring total hip replacement patients for potential wear problems. Mea...Continue Reading

References

Aug 7, 2003·Journal of Spinal Disorders & Techniques·Paul C McAfeeJanet Yu-Yahiro
Mar 3, 2005·The Journal of Bone and Joint Surgery. American Volume·Patrick TropianoThierry Marnay
Jul 16, 2005·Journal of Spinal Disorders & Techniques·Jean-Philippe LemaireFrançois Lavaste
Jun 10, 2009·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Svante BergHans Tropp
Dec 20, 2011·Journal of Biomechanics·Parshia MoghadasDuncan E T Shepherd
Aug 30, 2012·Clinical Orthopaedics and Related Research·Catherine Van Der StraetenKoen A De Smet
Nov 28, 2012·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Matthew F GornetJ J Jacobs
Jul 31, 2013·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Caroline SköldSvante Berg
Jan 23, 2014·The Spine Journal : Official Journal of the North American Spine Society·Christoph J SiepeMichael H Mayer

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Citations

Feb 9, 2016·Spine·Jose Eluf-Neto
Aug 26, 2016·Asian Spine Journal·Yu Chao LeeOrso Lorenzo Osti
Mar 23, 2017·Current Reviews in Musculoskeletal Medicine·Stephan N SalzmannFederico P Girardi
Mar 16, 2018·Journal of Comparative Effectiveness Research·Jack ZiglerLeena Patel
Nov 6, 2017·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Håvard FurunesKjersti Storheim
Oct 31, 2019·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·J KitzenP C P H Willems
Nov 15, 2019·Neurosurgery·Faheem A SandhuRolando Garica
Aug 11, 2019·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Carlo FormicaMatteo Formica
Jul 8, 2017·Journal of Orthopaedics and Traumatology : Official Journal of the Italian Society of Orthopaedics and Traumatology·Matteo FormicaLamberto Felli
Mar 1, 2021·The Spine Journal : Official Journal of the North American Spine Society·Dean C PerfettiAlexander M Satin
Mar 27, 2021·Journal of Occupational and Environmental Medicine·Kurt T HegmannJeffrey S Harris
May 26, 2018·The Spine Journal : Official Journal of the North American Spine Society·Jean-Yves LazennecMarc-Antoine Rousseau

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