Artikel
Outcomes of cervical total disc replacement with up to 5 years Follow-up: a prospective study of 384 patients
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Autoren
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Thierry Vila
- LDR Medical, Rosières-près Troyes, France
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Jean Huppert
- Clinique du Parc, Saint-Priest en Jarez, France
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Thierry Dufour
- CHR de Orléans, Orléans, France
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Jacques Beaurain
- CHRU Dijon Le Bocage Central, Dijon, France
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Jean-Marc Fuentes
- Clinique de Millénaire, Montpellier, Germany
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Jean-Marc Vital
- CHU Bordeaux Groupe Hospitalier Pellegrin, Bordeaux, France
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Jean-Paul Steib
- Hôpitaux Universitaires de Strasbourg, Strasbourg, France
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Pierre Bernard
- Clinique St Martin, Centre Aquitain du Dos, Mérignac, France
| Veröffentlicht: | 23. Oktober 2013 |
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Gliederung
Text
Purpose: A prospective and multi-centric study is ongoing in France since 2004 to evaluate the clinical and radiological outcomes of cervical disc replacement (CDR) in 384 patients. We present here the results of an intermediate analysis of the overall population, with up to 5 years of follow-up (FU).
Methodology: Indications were cervical degenerative disc disease at one or more levels (C3 to T1), leading to radiculopathy and/or myelopathy. Clinical outcomes (NDI 0-100%, VAS 0-100mm, SF-36) were completed prospectively by the patients and the investigators, as well as complications and revision surgeries. Range of Motion (ROM) and Heterotopic Ossification (HO) were also analyzed. Evaluations were performed pre-operatively and 1, 3, 6, 12, 24, 36 and 60 months after CDR. A single non-constrained prosthesis was used.
Results: The mean age of the patients was 44.8±8.1 years old (23-73). One-, 2-, 3- and 4-levels CDR concerned respectively 257, 108, 14 and 5 patients. All clinical outcomes improved: NDI decreased significantly compared to pre-op baseline (NDI averaged 51.9%, 35.5% and 25.7% at baseline, 1 month and 60 months respectively; p<0.0001 at all time-points). At 5 years, 87.8% of the patients had a NDI improvement compared to preop. The arm pain VAS score also decreased significantly compared to baseline at 1 month and up to 60 months (p<0.0001 at all time-points). The VAS score for neck pain followed the same pattern. As a consequence, the quality of life also improved (physical and mental component scales of the SF-36, analgesic use, return to work). Importantly, the outcomes improvement was maintained up to 5 years after CDR. Compared to pre-operative baseline, ROM was increased after CDR at the implanted levels but not at the adjacent levels. 4 patients underwent a revision procedure at one of the index levels, and 10 patients have been re-operated to treat another level of the cervical spine.
Conclusion: The population was representative of real-life conditions, as previous cervical surgeries, patients with work-related illness, or severe disc disease were not excluded. These results lead to the conclusion that CDR provides favorable clinical outcomes and maintains motion of the implanted levels.
