Acta Chir Orthop Traumatol Cech. 2016; 83(4):263-268 | DOI: 10.55095/achot2016/042

Radiological Changes after Interspinous Dynamic Stabilisation for Lateral Stenosis of Lumbar Spinal Canal: A Parallel Group Randomised TrialOriginal papers

J. MOHAR1,*, M. CIMERMAN2
1 Department of Spine Surgery and Paediatric Orthopaedics, Valdoltra Orthopaedic Hospital, Ankaran, Slovenia
2 Department of Traumatology, Ljubljana University Medical Centre, Ljubljana, Slovenia

PURPOSE OF THE STUDY:
Interspinous dynamic stabilisation devices (IDSDs) are used for stabilisation and indirect decompression of the spinal motion segment in minimally invasive treatment of degenerative conditions of lumbar spine. Good methodological quality studies on biomechanical effects of IDSDs are lacking in scientific literature. The purpose of this study was to evaluate the biomechanical effect of dynamic IDSD implantation on a spinal motion segment.

MATERIAL AND METHODS:
We conducted a parallel group randomised trial (RT) on twelve patients, comparing radiological stabilisation and indirect decompression outcome measures between groups of patients with an isolated degenerative condition of L4-L5 motion segment and unilateral L5 nerve root radiculopathy. One group of six patients was operated by decompression and dynamic IDSD implantation and the other group of six patients by decompression alone. The radiological assessment was performed 6 months postoperatively in all patients.

RESULTS:
Dynamic IDSD implantation significantly decreased segmental intervertebral angle (IA) and significantly increased segmental foraminal height (FH) and foraminal width (FW). The implantation had no effect on segmental range of motion (ROM) and posterior disc height (PDH).

CONCLUSIONS:
The studied dynamic IDSD improved radiological indirect decompression outcome measures while only partially improved radiological stabilisation outcome measures.
Oxford Centre for Evidence-Based Medicine 2011 Level 3: randomised trial with small effect size.

Keywords: lumbar spine, degenerative lateral stenosis, interspinous dynamic stabilisation, DIAM, randomised trial

Published: August 1, 2016  Show citation

ACS AIP APA ASA Harvard Chicago Chicago Notes IEEE ISO690 MLA NLM Turabian Vancouver
MOHAR J, CIMERMAN M. Radiological Changes after Interspinous Dynamic Stabilisation for Lateral Stenosis of Lumbar Spinal Canal: A Parallel Group Randomised Trial. Acta Chir Orthop Traumatol Cech. 2016;83(4):263-268. doi: 10.55095/achot2016/042. PubMed PMID: 28026727.
Share...
Download citation
  • BibTeX (.bib)
  • Bookends (.ris)
  • EasyBib (.ris)
  • EndNote (.enw)
  • EndNote 8 (.xml)
  • ISI WoS (.isi)
  • Medlars (.medlars)
  • Mendeley (.ris)
  • MODS (.xml)
  • Papers (.ris)
  • RefWorks (.txt)
  • RefManager (.ris)
  • RIS (.ris)
  • MS Word (.xml)
  • Zotero (.ris)
    • Open full article

    References

    1. ANASETTI, F., GALBUSERA, F., AZIZ, H. N., BELLINI, C. M., ADDIS, A., VILLA, T., TELI, M., LOVI, A., BRAYDA-BRUNO, M.: Spine stability after implantation of an interspinous device: an in vitro and finite element biomechanical study. J. Neurosurg. Spine, 13: 568-575, 2010. Go to original source... Go to PubMed...
    2. BELLINI, C. M., GALBUSERA, F., RAIMONDI, M. T., MINEO, G. V., BRAYDA-BRUNO M.: Biomechanics of the lumbar spine after dynamic stabilization. J. Spinal Disord. Tech., 20: 423-429, 2007. Go to original source... Go to PubMed...
    3. BORG, A., NURBOJA, B., TIMOTHY, J., CHOI, D.: Interspinous distractor devices for the management of lumbar spinal stenosis: a miracle cure for a common problem? Br. J. Neurosurg., 26: 445-449, 2012. Go to original source... Go to PubMed...
    4. GAZZERI, R., GALARZA, M., NERONI, M., FIORE, C., FAIOLA, A., PUZZILLI, F., CALLOVINI, G., ALFIERI, A.: Failure rates and complications of interspinous process decompression devices: a European multicenter study. Neurosurg. Focus, 39 (E14): 1-9, 2015. Go to original source... Go to PubMed...
    5. HRABÁLEK, L., MACHÁC, J., VAVERKA, M.: The DIAM spinal stabilisation system to treat degenerative disease of the lumbosacral spine. Acta Chir. orthop. Traum. čech., 76. 417-423, 2009. Go to original source...
    6. INUFUSA, A., AN, H. S., LIM, T. H., HASEGAWA, T., HAUGHTON, V. M., NOWICKI, B. H.: Anatomic changes of the spinal canal and intervertebral foramen associated with flexion-extension movement. Spine, 21: 2412-2420, 1996. Go to original source... Go to PubMed...
    7. JENIS, L. G., AN, H. S.: Spine update. Lumbar foraminal stenosis. Spine, 25: 389-394, 2000. Go to original source... Go to PubMed...
    8. KABIR, S. M., GUPTA, S. R., CASEY, A. T.: Lumbar interspinous spacers: a systematic review of clinical and biomechanical evidence. Spine, 35: E1499-1506, 2010. Go to original source... Go to PubMed...
    9. KIM, K. A., MCDONALD, M., PIK, J. H., KHOUEIR, P., WANG, M. Y.: Dynamic intraspinous spacer technology for posterior stabilization: case-control study on the safety, sagittal angulation, and pain outcome at 1-year follow-up evaluation. Neurosurg. Focus, 22: E7, 2007. Go to original source...
    10. KONG, D. S., KIM, E. S., EOH, W.: One-year outcome evaluation after interspinous implantation for degenerative spinal stenosis with segmental instability. J. Korean Med. Sci., 22: 330-335, 2007. Go to original source... Go to PubMed...
    11. LEE, C. K., RAUSCHNING, W., GLENN, W.: Lateral lumbar spinal canal stenosis: classification, pathologic anatomy and surgical decompression. Spine, 13: 313-320, 1988. Go to original source... Go to PubMed...
    12. LEE, J., HIDA, K., SEKI, T., IWASAKI, Y., MINORU, A.: An interspinous process distractor (X STOP) for lumbar spinal stenosis in elderly patients: preliminary experiences in 10 consecutive cases. J. Spinal Disord. Tech., 17: 72-77, 2004. Go to original source... Go to PubMed...
    13. MARSH, G. D., MAHIR, S., LEYTE, A.: A prospective randomised controlled trial to assess the efficacy of dynamic stabilisation of the lumbar spine with the Wallis ligament. Eur. Spine J., 23: 2156-2160, 2014. Go to original source... Go to PubMed...
    14. MORISHITA, Y., HIDA, S., NAITO, M., ARIMIZU, J., MATSUSHIMA, U., NAKAMURA, A.: Measurement of the local pressure of the intervertebral foramen and the electrophysiologic values of the spinal nerve roots in the vertebral foramen. Spine, 31: 3076-3080, 2006. Go to original source... Go to PubMed...
    15. PARCHI, P. D., EVANGELISTI, G., VERTUCCIO, A., PIOLANTI, N., ANDREANI, L., CERVI, V., GIANNETTI, C., CALVOSA, G., LISANTI, M.: Biomechanics of interspinous devices. Biomed. Res. Int., 2014: 1-7, 2014. Go to original source... Go to PubMed...
    16. PHILLIPS, F. M., VORONOV, L. I., GAITANIS, I. N., CARANDANG, G., HAVEY, R. M., PATWARDHAN, A. G.: Biomechanics of posterior dynamic stabilizing device (DIAM) after facetectomy and discectomy. Spine J., 6: 714-722, 2006. Go to original source... Go to PubMed...
    17. SCHULTE, L. M., O'BRIEN, J. R., MATTEINI, L. E., YU, W. D.: Change in sagittal balance with placement of an interspinous spacer. Spine, 36: E1302-1305, 2011. Go to original source... Go to PubMed...
    18. SOBOTTKE, R., SCHLÜTER-BRUST, K., KAULHAUSEN, T., RÖLLINGHOFF, M., JOSWIG, B., STÜTZER, H., EYSEL, P., SIMONS, P., KUCHTA, J.: Interspinous implants (X Stop, Wallis, Diam) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome? Eur. Spine J., 18: 1494-1503, 2009. Go to original source... Go to PubMed...
    19. TAMBURRELLI, F. C., PROIETTI, L., LOGROSCINO, C. A.: Critical analysis of lumbar interspinous devices failures: a retrospective study. Eur. Spine J., 20 (Suppl. 1): S27-35, 2011. Go to original source... Go to PubMed...
    20. VAN DEN AKKER-VAN MARLE, M. E., MOOJEN, W. A., ARTS, M. P., VLEGGEERT-LINKAMP, C. L., PEUL, W. C.; Leiden-The Hague Spine Intervention Prognostic Study Group (SIPS).: Interspinous process devices versus standard conventional surgical decompression for lumbar spinal stenosis: cost utility analysis. Spine J., 2014. [Epub ahead of print]
    21. WAN, Z., WANG, S., KOZANEK, M., XIA, Q., MANSFIELD, F. L., LÜ, G., WOOD, K. B., LI, G.: The effect of the X-Stop implantation on intervertebral foramen, segmental spinal canal length and disc space in elderly patients with lumbar spinal stenosis. Eur. Spine J., 21: 400-410, 2012. Go to original source... Go to PubMed...
    22. WILKE, H. J., DRUMM, J., HÄUSSLER, K., MACK, C., STEUDEL, W. I., KETTLER, A.: Biomechanical effect of different lumbar interspinous implants on flexibility and intradiscal pressure. Eur. Spine J.: 17: 1049-1056, 2008. Go to original source... Go to PubMed...
    23. ZHAO, Y., WANG, Y. P., QIU, G. X., ZHAO, H., ZHANG, J. G., ZHOU, X.: Efficacy of the Dynamic Interspinous Assisted Motion system in clinical treatment of degenerative lumbar disease. Chin. Med. J., 123: 2974-2977, 2010.
    24. ZUCHERMAN, J. F., HSU, K. Y., HARTJEN, C. A., MEHALIC, T. F., IMPLICITO, D. A., MARTIN, M. J., JOHNSON, D. R. 2nd., SKIDMORE, G. A., VESSA P. P., DWEYER, J. W., PUCCIO, S. T., CAUTHEN, J. C., OZUNA, R. M.: A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine, 30: 1351-1358, 2005. Go to original source... Go to PubMed...

    Return to the content