Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial

Mummaneni, Praveen V.; Burkus, J. Kenneth; Haid, Regis W.; Traynelis, Vincent C.; Zdeblick, Thomas A.

doi:10.3171/spi.2007.6.3.198

Cited by 568 publications

(459 citation statements)

References 46 publications

(51 reference statements)

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“…The goals of disc arthroplasty are to restore the intervertebral disc and foraminal height so as to prevent recurrence of nerve root compression [1], and maintain a physiological range of motion, and therefore limit segmental degeneration in adjacent levels [1]. However, artificial cervical disc implants may fail because of device-related complications such as dislocation, subsidence, vertebral body fracture and device wear [2].…”

Section: Introductionmentioning

confidence: 99%

Footprint mismatch in total cervical disc arthroplasty

et al. 2012

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Purpose Cervical disc arthroplasty has become a commonplace surgery for the treatment of cervical radiculopathy and myelopathy. Most manufacturers derive their implant dimensions from early published cadaver studies. Ideal footprint match of the prosthesis is essential for good surgical outcome. Methods We measured the dimensions of cervical vertebrae from computed tomography (CT) scans and to assess the accuracy of match achieved with the most common cervical disc prostheses [Bryan (Medtronic), Prestige LP (Medtronic), Discover (DePuy) Prodisc-C (Synthes)]. A total of 192 endplates in 24 patients (56.3 years) were assessed. The anterior-posterior and mediolateral diameters of the superior and inferior endplates were measured with a digital measuring system. Results Overall, 53.5 % of the largest device footprints were smaller in the anterior-posterior diameter and 51.1 % in the mediolateral diameter were smaller than cervical endplate diameters. For levels C5/C6 and C6/C7 an inappropriate size match was noted in 61.9 % as calculated from the anteroposterior diameter. Mismatch at the center mediolateral diameter was noted in 56.8 %. Of the endplates in the current study up to 58.1 % of C5/C6 and C6/ C7, and up to 45.3 % of C3/C4 and C4/C5 were larger than the most frequently implanted cervical disc devices. Conclusion Surgeons and manufacturers should be aware of the size mismatch in currently available cervical disc prostheses, which may endanger the safety and efficacy of the procedure. Undersizing the prosthetic device may lead to subsidence, loosening, heterotopic ossification and biomechanical failure caused by an incorrect center of rotation and load distribution, affecting the facet joints.

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Section: Introductionmentioning

confidence: 99%

Footprint mismatch in total cervical disc arthroplasty

et al. 2012

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“…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%

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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“…When more than one study addressed the outcome parameters in question, the results were consistent. The available evidence showed directness, meaning Heller [10] Cheng [5] Anderson [1] Mummaneni [13] Nabhan [15] Robertson [17] Country that studies compared the two alternatives in question head to head and addressed the same question as in our research question with respect to population, comparator and outcome. In summary, the strength of evidence for CTDR compared with fusion is moderate.…”

Section: Overall Study Qualitymentioning

confidence: 83%

“…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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Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial

Cited by 568 publications

References 46 publications

Footprint mismatch in total cervical disc arthroplasty

Footprint mismatch in total cervical disc arthroplasty

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

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

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