Mobile Total Disc Replacement Prosthesis Mobi‑ C, our Experience – Results of the Study with Five Years Follow‑up

Česká verzia

Authors: D. Štěpánek; D. Bludovský; M. Choc; S. Žídek; I. Holečková; V. Přibáň
Authors place of work: Neurochirurgické oddělení, LF UK a FN Plzeň
Published in the journal: Cesk Slov Neurol N 2014; 77/110(3): 343-348
Category: Short Communication

Summary

Aim:
To present clinical outcome and radiological findings in a group of patients five years after an implantation of mobile total disc replacement prostheses Mobi-C.

Material and methods:
Retrospection of prospectively collected data after five years from 17 patients with 18 disc prostheses Mobi-C implanted at the Department of Neurosurgery, Charles University Teaching Hospital in Plzen, Czech Republic. The surgery was indicated in the presence of symptoms of radiculopathy and/or myelopathy in correlation with soft disc herniation on magnetic resonance. Clinical condition was evaluated using the Visual Analogue Scale (VAS), modified Japanese Orthopaedic Association Scale (mJOA) and the Nurick Scale Range of motion of the operated spinal segment and the entire cervical spine was assessed with dynamic X rays. Heterotopic ossification was evaluated according to the Mehren classification. The results were statistically tested with nonparametric Wilcoxon test on the 0.05 significance level.

Results:
Range of motion five years after the implantation was not restricted, median remained the same. 7.0 (p = 0.2932), range of motion of the entire cervical spine was not significant; median increased from 36 to 48 (p = 0.0997). Heterotopic ossification grade 0 was found in 28%, bony fusion, degree IV, in 11%. Statistically significant improvement in neurological findings was found in all patients. The median score on VAS changed from 5.5 to 2 (p = 0.0009) and mJOA median from 16 to 18 (p = 0.0025).

Conclusions:
With respect to clinical outcome, total disc replacement with mobile prosthesis Mobi-C is an effective option in the treatment of cervical disc degeneration. The range of motion of the operated segment remained stable during five years after the implantation. No correlation was found between clinical outcome and range of motion of the prosthesis.

Key words:
prosthesis – total disc replacement – cervical spine – disc herniation – heterotopic ossification – spine mobility

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE “uniform requirements” for biomedical papers.

Zdroje

1. Fernström U. Arthroplasty with intercorporal endoprothesis in herniated disc and in painful disc. Acta Chir Scand Suppl 1966; 357:154– 159.

2. Cummins BH, Robertson JT, Gill SS. Surgical experience with an implanted arteficial cervical joint. J Neurosurg 1998; 88(6): 943– 948.

3. Bryan VE jr. Cervical motion segment replacement. Eur Spine J 2002; 11 (Suppl 2): S92– S97.

4. Le H, Thongtrangan I, Kim DH. Historical review of cervical arthroplasty. Neurosurg Focus 2004; 17(3): E1

5. Lee SH, Im YJ, Kim KT, Kim YH, Park WM, Kim K.Comparison of cervical spine biomechanics after fixed‑ and mobile‑ core artificial disc replacement: a finite element analysis. Spine 2011; 36(9):700– 708.

6. Phillips FM, Garfin SR. Cervical disc replacement. Spine 2005; 30 (Suppl 17): S27– S33.

7. Tu TH, Wu JC, Huang WC, Wu CL, Ko CC, Cheng H.The effects of carpentry on heterotopic ossification and mobility in cervical arthroplasty: determination by computed tomography with a minimum 2‑year follow‑up: clinical article. J Neurosurg Spine 2012; 16(6): 601– 609.

8. Sasso RC, Smucker JD, Hacker RJ, Heller JG. Artificial disc versus fusion: a prospective, randomized study with 2‑year follow‑up on 99 patients. Spine 2007; 32(26): 2932– 2933.

9. Kelly MP, Mok JM, Frisch RF, Tay BK. Adjacent segment motion after anterior cervical discectomy and fusion versus Prodisc‑ c cervical total disk arthroplasty: analysis from a randomized, controlled trial. Spine 2011; 36(15): 1171– 1179.

10. Auerbach JD, Anakwenze OA, Milby AH, Lonner BS,Balderston RA. Segmental contribution toward total cervical range of motion: a comparison of cervical disc arthroplasty and fusion. Spine 2011; 36(25): E1593–E 1599.

11. Denaro V, Papalia R, Denaro L, Martino A, Maffulli N.Cervical spinal disc replacement. J Bone Joint Surg Br 2009; 91(6): 713– 719.

12. Zhang X, Zhang X, Chen C, Zhang Y, Wang Z, Wang B et al. Randomized, controlled, multicenter, clinical trial comparing BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion in China. Spine 2012; 37(6): 433– 438.

13. Suchomel P. Degenerace krční meziobratlové ploténky – indikace a možnosti chirurgické léčby. Cesk Slov Neurol N 2008; 71/ 104(3): 246– 261.

14. Wu JC, Huang WC, Tu TH, Tsai HW, Ko CC, Wu CL et al. Differences between soft‑ disc herniation and spondylosis in cervical arthroplasty: CT‑ documented heterotopic ossification with minimum 2 years of follow‑up. J Neurosurg 2012; 16(2): 163– 171.

15. Singh K, Phillips F, Park D, Pelton M, An H, Goldberg E. Factors affecting reoperations after anterior cervical discectomy and fusion within and outside of a Federal Drug Administration investigational device exemption cervical disc replacement trial. Spine J 2012; 12(5): 372– 378.

16. Porchet F, Metcalf NH. Clinical outcomes with the Prestige II cervical disc: preliminary results from a prospective randomized clinical trial. Neurosurg Focus 2004; 17(3): E6.

17. Walraevens J, Demaerel P, Suetens P, van Calenbergh F, van Loon J, Vander Sloten J et al. Longitudinal prospective long‑term radiographic follow‑up after treatment of single‑level cervical disk disease with the Bryan Cervical Disc. Neurosurgery 2010; 67(3): 679– 687.

18. Suchomel P, Jurák L, Beneš V, Brabec R, Bradáč O,Elgawhary S. Clinical results and development of heterotopic ossification in total cervical disc replacement during a 4‑year follow‑up. Eur Spine J 2010; 19(2): 307– 315.

19. Barna M, Štulík J, Kryl J, Vyskočil T, Nesnídal P. Mobilní náhrada krční meziobratlové ploténky ProDisc‑ C: prospektivní monocentrická čtyřletá studie. Acta Chir Orthop Traumatol Cech 2012; 79(6): 512– 519.

20. Inoue S, Kataoka H, Tajima N. Assessment of treatment for low back pain. J Jpn Orthop Assoc 1986; 60: 391– 394.

21. Carlsson A. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain 1983; 16(1): 87– 101.

22. Nurick S. The natural history and the results of surgical treatment of the spinal cord disorder associated with cervical spondylosis. Brain 1972; 95(1): 101– 108.

23. Mehren C, Suchomel P, Grochulla F, Barsa P, Sourkova P, Hradil J et al. Heterotopic ossification in total cervical artificial disc replacement. Spine 2006; 31(24): 2802– 2806.

24. Beaurain J, Bernard P, Dufour T, Fuentes JM, Hovorka I, Huppert J et al. Intermediate clinical and radiological results of cervical TDR (Mobi‑ C) with up to 2 years of follow‑up. Eur Spine J 2009; 18(6): 841– 850.

25. Wilcoxon F. Individual Comparisons by Ranking Methods. Biometrics B 1945; 1(6): 80– 83.

26. Lee SE, Chung SK, Jahng TA. Early development and progression of heterotopic ossification in cervical total disc replacement. J Neurosurg Spine 2011; 16(1): 1– 6.

27. Park JJ, Quirno M, Cunningham MR, Schwarzkopf R,Bendo J, Spivak JM et al. Analysis of segmental cervical spine vertebral motion after prodisc‑ C cervical disc replacement. Spine 2010; 35(8): E285– E289.

28. Štulík J, Kryl J, Šebesta P, Vyskočil T, Krbec M, Trč T. Mobilní náhrada krční meziobratlové ploténky ProDisc‑ C: prospektivní monocentrická dvouletá studie. Acta Chir Orthop Traumatol Cech 2008; 75(4): 253– 261.

29. Yi S, Kim KN, Yang MS, Yang JW, Kim H, Ha Y et al. Difference in occurrence of heterotopic ossification according to prosthesis type in the cervical artificial disc replacement. Spine 2010; 35(16): 1556– 1561.

30. Eck JC, Humphreys SC, Lim TH, Jeong ST, Kim JG, Hodges SD et al. Biomechanical study on the effect of cervical spine fusion on adjacent‑ level intradiscal pressure and segmental motion. Spine 2002; 27(22): 2431– 2434.

31. Harrop JS, Youssef JA, Maltenfort M, Vorwald P, Jabbour P, Bono CM et al. Lumbar adjacent segment degeneration and disease after arthrodesis and total disc arthroplasty. Spine 2008; 33(15): 1701– 1707.

32. Hilibrand AS, Robbins M. Adjacent segment degeneration and adjacent segment disease: the consequences of spinal fusion? Spine J 2004; 4 (Suppl 6):90S‑ 194S.

33. Robertson JT, Papadopoulos SM, Traynelis VC. Assessment of adjacent‑ segment disease in patients treated with cervical fusion or arthroplasty: a prospective 2‑year study. J Neurosurg Spine 2005; 3(6): 417– 423.

34. Sasso RC, Best NM. Cervical kinematics after fusion and Bryan disc arthroplasty. J Spinal Disord Tech 2008; 21(1): 19– 22.

35. Reitman CA, Hipp JA, Nguyen L, Esses SI. Changes in segmental intervertebral motion adjacent to cervical arthrodesis: a prospective study. Spine 2004; 29(11): E221– E226.

36. Hilibrand AS, Carlson GD, Palumbo MA, Jones PK, Bohlman HH. Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am 1999; 81(4): 519– 528.

37. Alaranta H, Hurri H, Heliövaara M, Soukka A, Harju R. Flexibility of the spine: normative values of goniometric and tape measurements. Scand J Rehabi Med 1994; 26(3): 147– 154.

38. Guérin P, Obeid I, Gille O, Bourghli A, Luc S, Pointillart S et al. Sagittal alignment after single cervical disc arthroplasty. J Spinal Disord Tech 2012; 25(1): 10– 16.