Cervical Disc Arthroplasty (Prodisc-C): Analysis of 3 to 4- Year Follow Up Results

Czech version

Authors: L. Hrabálek; M. Vaverka; M. Houdek
Authors‘ workplace: Neurochirurgická klinika FN a LF UP Olomouc, přednosta: prof. MUDr. M. Houdek, CSc.
Published in: Rozhl. Chir., 2009, roč. 88, č. 11, s. 634-641.
Category: Monothematic special - Original

Overview

Aim:
The aim of this study was to assess the heterotopic ossification rate (HO), the range of motion of the operated, as well as the adjacent segments and the clinical condition of patients following cervical arthroplasty over a medium-term period.

Methods:
The entrance criteria for cervical arthroplasty (Prodisc-C, Synthes, USA) included: clinical symptoms of degenerative disorders of the cervical spine-axial and radicular pain or radicular compromise and their corresponding signs on MRI- soft disc hernia or spondylosis. The prospective study included 16 patients of 30–63 years of age (mean age 47.44) and the follow up duration was from 3 years and 3 months up to 4 years (mean duration 44 months). The following parameters were assessed prior to the procedure and 3–4 years after the procedure: clinical condition (NDI), axial pain and radicular pain scores ( VAS) and x-ray findings. Statistical tests were used to assess the outcomes.

Results:
3–4 years after the procedure, significant improvements in NDI by 48.13%, in cervical pain VAS by 65.75% and in radicular pain VAS by 67.31%, were demonstrated. All the above results were statistically significant.

Arthroplasty improved sagittal balance of the cervical spine and the resulting lordosis of the operated segment was more pronounced. HO was detected in 56.25% of the operated segments and resulted in a complete loss of the arthroplasty mobility in 18.75% of the segments. No statistical significant differencies in rates of NDI, axial VAS and radicular VAS changes were found between patients with HO grade III and IV and patients with HO grade 0–II.

No cases of the implant dislocation, subsidence or non-healing were observed, no subjects required surgical revisioning of the arthroplasty and no cases of „adjacent segment diseases“ were recorded.

Discussion:
based on the current literature data, complete disc replacement results in clinical outcomes, which are similar to those in patients with segment fusion. However, statistically significant reduction in rates of surgical revisions, reoperations and additional fixations was observed in subjects with arthroplasty. HO and spontaneous arthroplasty fusion is a new phenomenon, which may have a negative impact on the potentially saving effect of the arthroplasty on its adjacent segments.

Conclusion:
39–48 months following the Prodisc-C implantation, the below findings were demonstrated:

1. Statistically significant improvement in NDI by 48.13%, improvement in cervical pain VAS by 65.75% and radicular pain VAS improvement by 67.31%.

2. Arthroplasty resulted in improved sagittal balance of the cervical spine and the resulting lordosis of the operated segment was more pronounced.

3. HO was detected in 56.25% of the operated segments and resulted in a complete loss of the arthroplasty mobility in 18.75% of the segments.

4. No cases of the implant dislocation, subsidence or non-healing were observed, no subjects required surgical revisioning.

5. No cases of „adjacent segment diseases“ were recorded.

Key words:

cervical spine – arthroplasty – Prodisc-C – heterotopic ossification –adjacent segment disease

Sources

1. Hilibrand, A. S., Carlson, G. D., Palumbo, M. A., et al. Radiculopathy and myelopathy at segmental adjacent to the site of a previous anterior cervical arthrodesis. J. Bone and Joint Surg., 1999; 81-A: 519–528.

2. Katsuura, A., Hakuda, S., Saruhashi, Y., et al. Kyphotic malalignment after anterior cervical fusion is one of the factors promoting the degenerative process in adjacent intervertebral levels. Eur Spine J., 2001; 10: 320–324.

3. Wigfield, C., Gill, S., Nelson, R., et al. Influence of an artificial cervical joint compared with fusion on adjacent-level motion in the treatment of degenerative cervical disc disease. J. Neurosurg (Spine 1), 2002; 96: 17–21.

4. Mehren, Ch., Suchomel, P., Grochulla, F., et al. Heterotopic ossification in total cervical artificial disc replacement. Spine, 2006; 31: 2802–2806.

5. Štulík, J., Kryl, J., Šebesta, P., et al. Mobilní náhrada krční meziobratlové ploténky ProDisc-C: prospektivní monocentrická dvouletá studie. Acta Chir. ortop. Traum. čech., 2008; 75: 253–261.

6. Carlsson, A. M. Assessment of chronic pain: I. Aspects of the reliability and validity of the visual analogue scale. Pain, 1983; 16: 87–101.

7. Vernon, H., Mior, S. The Neck Disability Index: a study of reliability and validity. J. of Manipulative and Physiological Therapeutics, 1991; 14: 409–415.

8. Odom, G. L., Finney, W., Woodhall, B. Cervical disk lesions. J. Am. Med. Assoc., 1958; 166: 23–28.

9. Smith, G. W., Robinson, R. A. Anterolateral cervical disc removal and interbody fusion for cervical disc syndrome. Bull Johns Hopkins Med. Soc., 1955; 96: 223–224.

10. Hrabálek, L., Vaverka, M., Křupka, B., et al. Komplikace operací z předního přístupu pro degenerativní onemocnění krční páteře. Cesk. Slov. Neurol. N., 2007; 70/103(2): 201–206.

11. Rudinský, B., Hill, R. Intervertebrálna fúzia po použití biokeramickej náhrady NZ 2000 (hydroxyapatit) pri jeho dvojúrovňovej mikrodisektómii cervikálnej chrbtice. Acta Spondylologica, 2002; 1 (1): 16–20.

12. Suchomel, P., Barsa, P. Náhrada krční meziobratlové ploténky vložkou Cespace bez použití kosti či její náhrady. Prospektivní studie. Acta Spondylologica, 2004; 3 (1): 5–9.

13. Fernstrom, U. Arthroplasty with intracorporal endoprothesis in herniated disc and in painful disc. Acta chir. scand., 1966; Suppl 357: 154–159.

14. Reitz, H., Joubert, M. J. Intractable headache and cervicobrachialgia treated by complete replacement of cervical intervertebral disc with a metal prosthesis. S. Afr. Med. J., 1964; 38: 881–884.

15. Bertagnoli, R., Yue, J. J., Pfeiffer, F., et al. Early results after ProDisc-C cervical disc replacement. J. Neurosurg Spine, 2005; 2: 403–410.

16. Nabhan, A., Ahlhelm, F., Pitzen, T., et al. Disc replacement using Pro-Disc C versus fusion: a prospective randomised and controlled radiographic and clinical study. Eur. Spine J., 2007; 16: 423–430.

17. Nabhan, A., Ahlhelm, F., Shariat, K., et al. The ProDisc-C prothesis. Spine, 2007; 32: 1935–1941.

18. Prodisc-C cervical total disc replacement. US IDE clinical study design and results. www.fda.gov.

19. Dmitriev, A. E., Cunningham, B. W., Hu, N., et al. Adjacent level intradiscal pressure and segmental kinematics following a cervical total disc arthroplasty. Spine, 2005; 30: 1165–1172.