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Nucleus replacement technologies

Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2007

Domagoj Coric and Praveen V. Mummaneni

retroperitoneal, lateral, and posterior approaches. Limited exposure and annulotomy offer multiple revision options including TDR and fusion. The challenges of PDR include migration or expulsion risk of the device, as they are not generally fixed to endplates, and subsidence. 1–9 , 13 , 20 , 21 In the present study, we review the historical development of PDR devices and discuss those devices in current pre-clinical and clinical trials. We also present a classification system for this new generation of spinal implants. History and Evolution of Nucleus Replacement

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Kris Radcliff, Domagoj Coric and Todd Albert

C ervical total disc replacement (cTDR) in properly indicated patients with single-level cervical disc pathology has been demonstrated to achieve satisfactory neural decompression and clinical outcomes equivalent to or better 4 , 6 , 7 , 14–28 , 38 than anterior cervical discectomy and fusion (ACDF) in 7 different prospective, randomized, controlled US FDA trials. Single-level long-term data have been published on the Bryan disc, 34 Pro-Disc-C, 41 and Prestige ST disc, 8 but this is the first report on the 5-year investigational device exemption (IDE

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Domagoj Coric, Joseph Cassis, John D. Carew and Margaret O. Boltes

C ervical arthroplasty continues to gain popularity. 10 , 17 , 22–24 The era of cervical TDR in the US was ushered in with the FDA approval in 2007 of the Prestige ST cervical disc system (Medtronic), 22 followed by the Prodisc-C in 2008 (Synthes), 24 and most recently the Bryan disc in 2009 (Medtronic). 17 There are an additional 7 cervical arthroplasty devices that have completed or are active in the US FDA IDE process. Cervical disc arthroplasty offers several theoretical advantages in comparison with ACDF in the treatment of select patients with

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Domagoj Coric and Tim Adamson

, 11 , 14 , 15 , 22 , 30 Minimally invasive surgery reduces approach-related complications with concomitant shorter recovery times. 1 , 3 , 27 Cervical arthroplasty maintains the familiar anterior approach to the cervical spine used in ACDF, but also shares similar approach-related complications. The advantages of arthroplasty include maintenance of motion, but requires implantation of a mechanical device. Complications associated with arthroplasty include mechanical implant failure, including displacement and wear, wear debris, and heterotopic ossification with

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Cheerag D. Upadhyaya, Jau-Ching Wu, Gregory Trost, Regis W. Haid, Vincent C. Traynelis, Bobby Tay, Domagoj Coric and Praveen V. Mummaneni

these trials participated in this analysis. The coauthors had access to unpublished as well as published summary data from each of these trials. We obtained unpublished, original summary data from each of the trials to complete our analysis. Statistics were calculated utilizing fixed effects and random effects assumptions to calculate a pooled RR for categorical variables and WMD for continuous variables. A random effects model typically yields a more conservative effect estimate. Given that the trials were studying different devices, we thought it prudent to use

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Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site

Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2005

Domagoj Coric, Frederick Finger and Peggy Boltes

treated level and may potentially decrease the occurrence of adjacent-level degeneration. 7 , 12 , 17 A prospective randomized controlled multicenter US Food and Drug Administration investigational device exemption study has been completed in which we compared the clinical outcomes obtained in patients treated with the Bryan Cervical Disc System (Medtronic Sofamor Danek, Memphis, TN) and those obtained in patients who underwent ACDF. In the present study we report the early results acquired from a single investigational site, documenting the safety and effectiveness

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Domagoj Coric, John Parish and Margaret O. Boltes

There has been a steady evolution of cervical total disc replacement (TDR) devices over the last decade resulting in surgical technique that closely mimics anterior cervical discectomy and fusion as well as disc design that emphasizes quality of motion. The M6-C TDR device is a modern-generation artificial disc composed of titanium endplates with tri-keel fixation as well as a polyethylene weave with a polyurethane core. Although not yet approved by the FDA, M6-C has finished a pilot and pivotal US Investigational Device Exemption (IDE) study. The authors present the surgical technique for implantation of a 2-level M6-C cervical TDR device.

The video can be found here:

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Domagoj Coric, Praveen V. Mummaneni, Vincent Traynelis and Jeffrey Wang

T here has been a steady evolution of devices for cervical total disc replacement (TDR) over the last decade that has resulted in a surgical technique that closely mimics that for anterior cervical discectomy and fusion (ACDF); disc designs now incorporate novel bio-materials and biomechanics that emphasize quality of motion. The efficacy of cervical arthroplasty has been established with a firm basis of evidence wrought through peer-reviewed published data reported in multiple prospective, randomized, controlled investigational device exemption (IDE

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Domagoj Coric, Kenneth Pettine, Andrew Sumich and Margaret O. Boltes

of the chondrocytic disc cell's inability to produce and maintain the ECM. 3 , 10 , 11 , 38 , 41 , 52 Surgical procedures focused on addressing nucleus pathology can be broadly categorized into 3 distinct areas: nucleus replacement, nucleus augmentation, and nucleus repair ( Fig. 1 ). There are currently no FDA-approved devices/drugs in any of these categories. Nucleus replacement involves surgical removal of nucleus tissue followed by device placement, generally elastomeric (Prosthetic Disc Nucleus [PDN], Raymedica) or mechanical (NUBAC, Pioneer Surgical

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Domagoj Coric, John A. Wilson and David L. Kelly Jr

–318, 1981 9. Garber JN : Abnormalities of the atlas and axis vertebrae—congenital and traumatic. J Bone Joint Surg (Am) 46 : 1782 – 1791 , 1964 Garber JN: Abnormalities of the atlas and axis vertebrae—congenital and traumatic. J Bone Joint Surg (Am) 46: 1782–1791, 1964 10. Garfin SR , Botte MJ , Waters RL , et al : Complications in the use of the halo fixation device. J Bone Joint Surg (Am) 68 : 320 – 325 , 1986 Garfin SR, Botte MJ, Waters RL, et al: Complications in the use of the