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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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Edward C. Benzel

individuals. This cannot help but be reflected in the results. Conversely, those randomized to the treatment (noncontrol) group are usually happy or satisfied with their randomization results, and this is often reflected in their perception of their own clinical outcomes. These variables are particularly relevant in return-to-work status, disability, and quality of life. Finally, short-term (2-year) analyses do not reveal the entire story. Do these devices wear out? What happens to the device–endplate interface over time? What happens to the patient and the device in 10

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Ricardo V. Botelho

agree that the mean neurological success rates are not related to any of these devices (arthroplasty or fusion devices), but to surgical decompression of affected nerve roots. Some authors question if secondary outcomes may be validated in the absence of proven primary outcomes. 2 In my opinion, the DAF was not studied as a primary outcome, in part due to the noninferiority design of the study. The primary argument for the use of arthroplasty is that it decreases the DAF and that fusion can, in turn, cause or increase the DAF. The designs of noninferiority trials

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The future in the care of the cervical spine: interbody fusion and arthroplasty

Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004

Praveen V. Mummaneni and Regis W. Haid

procedures involving knees and hips, the implants are subject to repetitive stresses and generate wear-related debris. Tribology (the study of friction, lubrication, and wear of interacting surfaces in relative motion) has been a primary focus for the developers of large-joint prostheses in recent years. Like other total joints, artificial disc prostheses have articulating surfaces that will wear down during the life of the implant. With the potential increase in use of articulating devices in the cervical spine in coming years, it is necessary to evaluate the amount of

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Michael Y. Wang and Praveen V. Mummaneni

), or expandable cages ( Fig. 2 ) (Globus Medical or Synthes Spine). These interbody devices were filled with rhBMP-2 (InFuse, Medtronic Sofamor Danek). Posterior supplemental fixation was performed with the use of Viper percutaneous pedicle screws and connecting rods (DePuy Spine) introduced through the proximal or distal screw entry site. The screw insertion technique was based on using primarily anteroposterior fluoroscopy, and no image guidance was used. Posterolateral intersegmental fusion was achieved at levels without interbody fusion by exposing the facet

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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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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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Erica F. Bisson, Deshpande V. Rajakumar and Praveen V. Mummaneni

spondylolisthesis reduction (Rajakumar et al.), as well as a comparison of expandable versus static interbody devices for transforaminal lumbar interbody fusion (Hawasli et al.). In addition, this issue aims to review and present pertinent outcomes for commonly used techniques such as tubular microdiscectomy to treat degenerative spine disease (Clark et al.), MIS fusion for degenerative spondylolisthesis (Mummaneni et al.), and more advanced techniques applicable to spinal deformity treatment including MIS pre-psoas fusion surgery (DiGiorgio et al.), MIS lateral hyperlordotic

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J. Kenneth Burkus, Regis W. Haid Jr., Vincent C. Traynelis and Praveen V. Mummaneni

control group (broken line) . Adjacent-Segment Ossification Adjacent-level ossification was not a specific data point captured in the study; ossification patterns and ankylosis were reviewed. The anterior flange of the investigational Prestige ST device that fixes the implant to the vertebral bodies extends only 7 mm beyond the disc space. The overall height of the Prestige devices in the study ranged from 20.6 to 22.6 mm for the 6- to 8-mm–height devices. The most commonly used anterior cervical plate is 23 mm for single-level cases. Dysphagia and Dysphonia

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Michael Y. Wang, Guillermo Pineiro and Praveen V. Mummaneni

, 1995 13 Guyer DW , Yuan HA , Werner FW , Frederickson BE , Murphy D : Biomechanical comparison of seven internal fixation devices for the lumbosacral junction . Spine 12 : 569 – 573 , 1987 14 Holland NR , Lukaczyk TA , Riley LH III , Kostuik JP : Higher electrical stimulus intensities are required to activate chronically compressed nerve roots. Implications for intraoperative electromyographic pedicle screw testing . Spine 23 : 224 – 227 , 1998 15 Holly LT , Foley KT : Percutaneous placement of posterior cervical