Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease

Murrey, Daniel B.; Janssen, Michael; Delamarter, Rick B.; Goldstein, Jeffrey A.; Zigler, Jack E.; Tay, Bobby; Darden, Bruce V.

doi:10.1016/j.spinee.2008.05.006

Cited by 521 publications

(413 citation statements)

References 26 publications

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“…A parametric statistical analysis using the Wald's test was used to determine if significant differences (p \ 0.05) in the wear rates within or between groups was present. Wear volume was calculated using the density of PEEK, 1.30 g/mL 3 . Light microscopy was used to characterize the articulating wear surfaces using a Nikon Multizoom AZ100.…”

Section: Methodsmentioning

confidence: 99%

“…The history of TDR goes back more than 40 years starting with the use of stainless steel (SS) balls [1,2] to more recent implants that consist of a diverse selection of material combinations, such as polyethylene on metal, metal on metal and elastomeric constructs. Subsequently, the clinical outcome of many of these modern implants have shown promise in providing equivalent or superior clinical performance to ACDF in randomized, controlled studies [3][4][5][6]. However, currently ACDF still remains the gold standard of care.…”

Section: Introductionmentioning

confidence: 99%

“…Therefore, as compared to ACDF, TDR devices face additional issues, such as wear and biodurability. Given that these devices are indicated for skeletally mature patients (C18 years of age) [3][4][5], the durability of the device should be evaluated as part of the preclinical evaluation, since these prostheses are expected to last for the lifetime of the recipient. To assess the durability of motion-preserving devices, in vitro wear simulations are performed as a component of preclinical safety and effectiveness evaluations to satisfy medical device directives (MDD) and investigational device exemption (IDE) submissions.…”

Section: Introductionmentioning

confidence: 99%

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The use of self-mating PEEK as an alternative bearing material for cervical disc arthroplasty: a comparison of different simulator inputs and tribological environments

Brown

Bao

2012

Eur Spine J

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Purpose The hypothesis for this study was that the simulated wear behavior of a hydroxyapatite coated, selfmating PEEK cervical disc arthroplasty device would be dependent on the simulated testing environment. Methods Five groups of devices were evaluated under suggested ASTM and ISO load and motion profiles. The groups utilized different testing frequencies and protein content of simulator fluid, in addition to assessing the potential for third body wear. The average wear rates were determined using linear regression analysis with a generalized estimating equation. Significant differences between groups were determined using the Wald's test. Results The simulated wear behavior was shown to be highly dependent on the testing environment, where protein content more than decreasing the cyclic loading frequency resulted in increased wear, but was not dependent on the suggested load and motion profiles. It was demonstrated that a self-mating PEEK cervical disc arthroplasty device has wear rates that are similar to existing material combinations for cervical disc arthroplasty. Conclusions This study showed that at a time when data from retrieval analyses is deficient, it is important to test the wear resistance of cervical disc arthroplasty devices under various conditions. Long-term clinical results and ongoing implant retrievals are required for validation between clinical performance and simulator inputs.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The use of self-mating PEEK as an alternative bearing material for cervical disc arthroplasty: a comparison of different simulator inputs and tribological environments

Brown

Bao

2012

Eur Spine J

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“…We reviewed single institution prospective data from a randomized trial comparing single-level ACDF and CDA in cervical disc disease 1. Data collected included demographics, Health-Related Quality of Life outcome scores (neck disability index [NDI] and SF-36), and quality-adjusted life year (QALY) utility scores.…”

Section: Methodsmentioning

confidence: 99%

Cost-utility analysis of anterior cervical discectomy and fusion versus cervical disc arthroplasty

Warren

Hoelscher

Ricart-Hoffiz

et al. 2011

Evidence-Based Spine-Care Journal

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“…steroids) and mental illness. Most of the RCTs were conducted in the USA as 'Food and Drug Administration investigational device exemption studies' [1,10,13,14]. One study was based in Germany [15] and one in China [5].…”

Section: Study Characteristicsmentioning

confidence: 99%

Artificial total disc replacement versus fusion for the cervical spine: a systematic review

2010

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Cervical total disc replacement (CTDR) has been increasingly used as an alternative to fusion surgery in patients with pain or neurological symptoms in the cervical spine who do not respond to non-surgical treatment. A systematic literature review has been conducted to evaluate whether CTDR is more efficacious and safer than fusion or non-surgical treatment. Published evidence up to date is summarised qualitatively according to the GRADE methodology. After 2 years of follow-up, studies demonstrated statistically significant non-inferiority of CTDR versus fusion with respect to the composite outcome 'overall success'. Single patient relevant endpoints such as pain, disability or quality of life improved in both groups with no superiority of CTDR. Both technologies showed similar complication rates. No evidence is available for the comparison between CTDR and non-surgical treatment. In the long run improvement of health outcomes seems to be similar in CTDR and fusion, however, the study quality is often severely limited. After both interventions, many patients still face problems. A difficulty per se is the correct diagnosis and indication for surgical interventions in the cervical spine. CTDR is no better than fusion in alleviating symptoms related to disc degeneration in the cervical spine. In the context of limited resources, a net cost comparison may be sensible. So far, CTDR is not recommended for routine use. As many trials are ongoing, reevaluation at a later date will be required. Future research needs to address the relative effectiveness between CTDR and conservative treatment.

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Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease

Cited by 521 publications

References 26 publications

The use of self-mating PEEK as an alternative bearing material for cervical disc arthroplasty: a comparison of different simulator inputs and tribological environments

The use of self-mating PEEK as an alternative bearing material for cervical disc arthroplasty: a comparison of different simulator inputs and tribological environments

Cost-utility analysis of anterior cervical discectomy and fusion versus cervical disc arthroplasty

Artificial total disc replacement versus fusion for the cervical spine: a systematic review

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