Abstract
Purpose
The purpose of the present study is to evaluate the early clinical and radiographic outcome in patients operated with Discocerv® Cervidisc Evolution semi-constrained cervical mobile prosthesis (Discocerv®), made of ceramic materials (Zirconia & Alumina).
Study design
This is a monocentric prospective noncomparative study.
Patient sample
Seventeen consecutive patients (8 men/9 women) were enrolled in the study so far. Mean age was 46.1 ± 7.9 years (33–62).
Methods
Patients in this series underwent one or two level total cervical disc replacement (TCDR) with Discocerv for disc herniation (n = 13), stenosis (n = 2) or discopathy (n = 1). Mean follow up was 4.8 ± 1.8 months (0–7.2).
Outcome measures
Clinical evaluation criteria included: VAS 1–100 mm self-reported cervical and radicular pain, neck disability index (NDI), symptoms evolution (ODOM score), work status, patient satisfaction index (PSI), mobility preservation. Prior to surgery VAS self-reported cervical and radicular pain were 62 mm (4–95) and 67 mm (2–96) respectively. NDI was 25/50 (9/50–37/50). Out of the active population (88%) 66% of patients were in sick leave for cervical symptoms. Radiographic criteria such as intervertebral mobility of the operated level were also assessed.
Results
Sixteen patients had a one level total cervical disc replacement (C3C4 n = 1, C4C5 n = 3, C5C6 n = 9, C6C7 n = 3. One patient had C5C6 and C6C7 total cervical disc replacement. Surgery duration was 67.1 ± 20.2 min (35–120). Hospital stay was 3.6 ± 1.5 days (2–7). No pre-operative or post-operative complications were reported in this series, except for excessive bleeding in one patient without any further consequences. About 47% of active patients resumed their previous work within the first 3 months after surgery. The ODOM score showed 100% excellent and good results. Three months post-operatively, mean VAS self-reported cervical and radicular pain decreased to 13 mm (0–60) and 5 mm (0–20) respectively and NDI decreased to 11/50 (0–24). All patients were satisfied with the results so far. Quantitative radiographic analysis showed satisfactory restoration of cervical mobility at the operated levels, with mean intervertebral mobility of 4.9° ± 5.6° (0 to 19.0°) in flexion-extension and 8.4° ± 4.1° (2.7°–16.9°) in lateral bending.
Conclusion
Early results with Discocerv® Cervidisc Evolution cervical prosthesis are encouraging. However, further follow-up on a larger group is necessary to confirm these findings.
Résumé
Objectif
L’objectif de cette étude a été d’évaluer les résultats cliniques et radiologiques préliminaires dans une série de patients opérés avec la prothèse discale cervicale semi-contrainte Discocerv® Cervidisc Evolution, réalisée en céramique (Zirconium et Alumina)
Protocole d’étude
Cette étude est de type monocentrique prospective non-comparative.
Patients
Dix-sept patients consécutifs (8 hommes/9 femmes) ont été inclus dans l’étude à ce jour. L’age moyen était de 46.1 ± 7.9 ans (33–62).
Méthodes
Tous les patients on subi une arthroplastie totale cervicale à l’aide de la prothèse Discocerv. Les diagnostics étaient : hernie discale (n = 13), sténose cervicale (n = 2), discopathie (n = 1). Le suivi moyen était de 4.8 ± 1.8 mois (0–7.2).
Critères d’évaluation
Les critères d’évaluation ont été: les douleurs cervicales et radiculaires mesurées sur une EVA de 1 à 100 mm, le score Neck Disability Index (NDI), l’évolution des symptômes (score ODOM), l’activité professionnelle, la satisfaction du patient (Patient Satisfaction Index: PSI), la restauration de la mobilité de niveaux instrumentés. La mobilité intervertébrale aux niveaux instrumentés a été également évaluée. Avant la chirurgie, les douleurs cervicale et radiculaire moyennes sur la EVA étaient de 62 mm (4–95) et 67 mm (2–96) respectivement. Le NDI moyen était de 25/50 (9/50–37/50). 66% de la population active (représentant 88% de la population totale) était en arrêt maladie à cause des symptômes cervicaux.
Résultats
Seize patients ont eu une arthroplastie mono étagée (C3C4 n = 1, C4C5 n = 3, C5C6 n = 9, C6C7 n = 3). Un patient a eu une double arthroplastie (C5C6 et C6C7). La durée opératoire moyenne a été de 67.1 ± 20.2 min (35–120). La durée moyenne d’hospitalisation a été de 3.6 ± 1.5 jours (2–7). Aucune complication per-opératoire ou post-opératoire n’a été constatée dans cette série, excepté un cas de saignement abondant, sans conséquences pour le patient. 47% de la population active a repris le travail durant les trois premiers mois après la chirurgie. Le score ODOM montrait des résultats bons ou excellents dans 100% des cas de cette série. Trois mois après la chirurgie, l’EVA moyenne cervicale et radiculaire était de 13 mm (0–60) et 5 mm (0–20) respectivement, et le NDI était de 11/50 (0; 24/50). Tous les patients se sont déclarés satisfaits du résultat de l’opération. Les analyses quantitatives des critères radiographiques ont montré une bonne restauration de la mobilité intervertébrale aux niveaux instrumentés, avec une mobilité moyenne en flexion/extension de 4.9° ± 5.6° (0°–19.0°) et en inclinaison latérale de 8.4° ± 4.1° (2.7°–16.9°).
Conclusion
Les résultats préliminaires obtenu avec la prothèse cervicale Discocerv® Cervidisc Evolution sont très prometteurs. Néanmoins, un suivi prolongé sur une série plus importante est nécessaire afin de pouvoir confirmer de façon définitive les résultats de cette étude.
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Ramadan, A.S., Mitulescu, A. & Schmitt, P. Total cervical disc replacement with the Discocerv® (Cervidisc Evolution) cervical prosthesis: early results of a second generation. Eur J Orthop Surg Traumatol 17, 513–520 (2007). https://doi.org/10.1007/s00590-007-0242-0
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DOI: https://doi.org/10.1007/s00590-007-0242-0