A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of Lumbar Total Disc Replacement With the CHARITÉ ™ Artificial Disc Versus Lumbar Fusion

McAfee, Paul C.; Cunningham, Bryan W.; Holsapple, Gwen; Adams, Karen; Blumenthal, Scott L.; Guyer, Richard D.; Dmietriev, Anton; Maxwell, James; Regan, John J.; Isaza, Jorge

doi:10.1097/01.brs.0000170561.25636.1c

Cited by 284 publications

(155 citation statements)

References 16 publications

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“…McAfee et al [34] reported an operative level ROM of 113.6% of preoperative status in TDR group at 24 months (7.4 ± 5.28), and the mean ROM in fusion group has dropped to 1.1 ± 0.87 (with 91.9% patient gaining successful lumbar fusion). In Delamarter's study [23], the result showed significantly better motility at L4-L5 for disc replacement patients (10.5°at 12 months) comparing with the fusion patients (P \ 0.05), but at L5-S1 the differences between two groups was not statistically significant at 6-month point.…”

Section: Qualitative Resultsmentioning

confidence: 99%

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A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease

Zhu

Han

et al. 2010

Eur Spine J

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Lumbar fusion has been developed for several decades and became the standard surgical treatment for symptomatic lumbar degenerative disc disease (DDD). Artificial total disc replacement (TDR), as an alternative for spinal arthrodesis, is becoming more commonly employed treating lumbar DDD. It is still uncertain whether TDR is more effective and safer than lumbar fusion. To systematically compare the effectiveness and safety of TDR to that of the fusion for the treatment of lumbar DDD, we performed a meta-analysis. Cochrane review methods were used to analyze all relevant randomized controlled trials published up to July 2009. Five relevant randomized controlled trials involving 837 patients were identified. Patients in TDR group have sightly better functioning and less back or leg pain without clinical significance, and significantly higher satisfaction status in TDR group compared with lumbar fusion group at the 2-year followup. But these outcomes are highly influenced by the study with BAK cage interbody fusion, the function/pain and patient satisfaction status are no longer significantly different between two groups after excluding this study. At 5 years, these outcomes are not significantly different between comparing groups. The complication and reoperation rate of two groups are similar both at 2 and at 5 years. In conclusion, TDR does not show significant superiority for the treatment of lumbar DDD compared with fusion. The benefits of motion preservation and the long-term complications are still unable to be concluded. More highquality RCTs with long-term follow-up are needed.

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Section: Qualitative Resultsmentioning

confidence: 99%

“…These reports were based upon five independent continuous clinical randomized control trials, reporting for different follow-up periods or containing separated results. Nine reports from the five RCTs with the relevant information are eventually included involving 837 patients [2,3,9,18,20,34,36,41,48].…”

Section: Description Of Studiesmentioning

confidence: 99%

A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease

Zhu

Han

et al. 2010

Eur Spine J

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“…Other studies however continue to report TDR flexion-extension ROM values even below this suggested 2°threshold [13,17]. A recent study suggests that a threshold angle of at least 4.6°between flexion-extension radiographs must be measured before one can be certain that the ROM of the TDR is not 0 [15].…”

Section: Discussionmentioning

confidence: 97%

“…With considerable ([5°) segmental flexion-extension range of motion (ROM), TDRs have been correlated to better clinical outcomes [7], and suggested to have reduced long-term risk in the development of radiographic adjacent level degeneration [8,18]. Correct surgical placement of the TDR has been reported to be essential in achieving these improved clinical outcomes as well as flexion-extension ROM [3,17]. Accurate post-operative measurement of TDR ROM is thus important in gauging both implant performance and surgical outcome.…”

Section: Introductionmentioning

confidence: 99%

Radiographic total disc replacement angle measurement accuracy using the Oxford Cobbometer: precision and bias

et al. 2008

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Total disc replacement (TDR) clinical success has been reported to be related to the residual motion of the operated level. Thus, accurate measurement of TDR range of motion (ROM) is of utmost importance. One commonly used tool in measuring ROM is the Oxford Cobbometer. Little is known however on its accuracy (precision and bias) in measuring TDR angles. The aim of this study was to assess the ability of the Cobbometer to accurately measure radiographic TDR angles. An anatomically accurate synthetic L4-L5 motion segment was instrumented with a CHARITE artificial disc. The TDR angle and anatomical position between L4 and L5 was fixed to prohibit motion while the motion segment was radiographically imaged in various degrees of rotation and elevation, representing a sample of possible patient placement positions. An experienced observer made ten readings of the TDR angle using the Cobbometer at each different position. The Cobbometer readings were analyzed to determine measurement accuracy at each position. Furthermore, analysis of variance was used to study rotation and elevation of the motion segment as treatment factors. Cobbometer TDR angle measurements were most accurate (highest precision and lowest bias) at the centered position (95.5%), which placed the TDR directly inline with the x-ray beam source without any rotation. In contrast, the lowest accuracy (75.2%) was observed in the most rotated and off-centered view. A difference as high as 4°between readings at any individual position, and as high as 6°between all the positions was observed. Furthermore, the Cobbometer was unable to detect the expected trend in TDR angle projection with changing position. Although the Cobbometer has been reported to be reliable in different clinical applications, it lacks the needed accuracy to measure TDR angles and ROM. More accurate ROM measurement methods need to be developed to help surgeons and researchers assess radiological success of TDRs.

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“…The figures of the SB III device in the paper published by Putzier et al clearly show a positioning of the prostheses which are too anterior. McAfee et al [11] demonstrated a statistical correlation between prosthesis positioning and clinical outcomes at 2 years. Patients with poor implant placement had statistically worse clinical outcomes than patients with optimal placement.…”

mentioning

confidence: 98%

Letter to the Editor concerning “Charité total disc replacement: clinical and radiographical results after an average follow-up of 17 years” (M. Putzier et al.)

Büttner-Janz

2006

Eur Spine J

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A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of Lumbar Total Disc Replacement With the CHARITÉ ™ Artificial Disc Versus Lumbar Fusion

Cited by 284 publications

References 16 publications

A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease

A meta-analysis of artificial total disc replacement versus fusion for lumbar degenerative disc disease

Radiographic total disc replacement angle measurement accuracy using the Oxford Cobbometer: precision and bias

Letter to the Editor concerning “Charité total disc replacement: clinical and radiographical results after an average follow-up of 17 years” (M. Putzier et al.)

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