Zeitschrift fur Orthopadie und ihre Grenzgebiete · 2005
[Artificial discs: review, current status, outlook].
Аннотация на английскомСтатьяОбзорНазвание и аннотация: Перевод в очереди
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Krämer J, Kleinert H, Senge A, Rubenthaler F
Аннотация
AIM: This paper gives an overview of the current status of artificial discs for the lumbar spine.
METHODS: Recent publications and overviews in the literature with pro and contra opinions and the latest procedure of FDA approval are presented and discussed. Despite arguments to the contrary, an FDA panel is in favour of the premarket approval application for the Charité artificial disc because of good late follow-up results. Other lumbar artificial discs will follow.
RESULTS: Follow-up studies only exist for the Charité and Prodisc endoprotheses. The results are comparable to those of lumbar fusion. However, randomized controlled studies are still missing.
CONCLUSION: Proponents for lumbar artificial discs stand against the criticism of an unpredictable treatment for a condition that cannot be diagnosed with any precision. The current model should be a controlled indication with second opinions followed by professional surgery in spine centers.
METHODS: Recent publications and overviews in the literature with pro and contra opinions and the latest procedure of FDA approval are presented and discussed. Despite arguments to the contrary, an FDA panel is in favour of the premarket approval application for the Charité artificial disc because of good late follow-up results. Other lumbar artificial discs will follow.
RESULTS: Follow-up studies only exist for the Charité and Prodisc endoprotheses. The results are comparable to those of lumbar fusion. However, randomized controlled studies are still missing.
CONCLUSION: Proponents for lumbar artificial discs stand against the criticism of an unpredictable treatment for a condition that cannot be diagnosed with any precision. The current model should be a controlled indication with second opinions followed by professional surgery in spine centers.