Percutaneous interspinous dynamic stabilization (In-Space) in patients with degenerative disease of the lumbosacral spine – a prospective study
Authors:
L. Hrabálek 1; T. Wanek 1; J. Macháč 1; M. Vaverka 1; K. Langová 2
; O. Kalita 1; D. Krahulík 1; V. Novák 1; M. Houdek 1
Authors place of work:
Neurochirurgická klinika LF UP a FN Olomouc, přednosta: Prof. MUDr. Michael Houdek, CSc.
1; Ústav lékařské biofyziky LF UP Olomouc, přednosta: Prof. RNDr. Hana Kolářová, CSc.
2
Published in the journal:
Rozhl. Chir., 2012, roč. 91, č. 6, s. 311-316.
Category:
Original articles
Summary
Introduction:
Interspinous spacers are supposed to reduce the segmental extension with a decrease in the expansion of yellow ligaments into the spinal canal, thus avoiding the dynamic narrowing of the spinal canal and compression of nerve roots. The aim of this study was to evaluate clinical outcomes and post-operative complications during one year in patients mostly having suffered from spinal stenosis and treated by In-Space interspinous spacer (Synthes, USA).
Material and methods:
A total of 25 patients aged between 25 and 73 (average age 52.6) years, including 18 males and 7 females, with degenerative disease of the lumbosacral spine were indicated for surgery and prospectively followed up. The patients were operated on under general anaesthesia in the prone position, using a minimally invasive lateral percutaneous approach, under fluoroscopic control. The ODI and VAS values as well as X- rays (Range Of Motion and Sagittal angle of the operated segment) 6 and 12 months after the surgery were compared to each other and to those before surgery. The results were statistically analyzed.
Results:
The average ODI of the group was 47.2% before surgery and 17.48% 6 months (22.76% 12 months) after surgery, showing a statistically significant improvement by 63% (52% after 12 months). The average VAS of the group was 6.64 points before surgery and 2.96 points 6 months (2.8 points 12 months) after surgery, which showed a statistically significant improvement by 55.4% after 6 months (57.8% after 12 months) when compared to preoperative status. After surgery the lordotic sagittal angle remained in all cases; one year after surgery the angle increased due to the slight sinking of some implants. The extent of segmental motion was minimally changed (6.1o 6 months and 7.24o 12 months after surgery). No serious complications occurred. The effect of interspinous implants proved insufficient in two cases (one year and two years after surgery) and conversion to arthrodesis or decompression was performed.
Conclusions:
- Percutaneous, minimally invasive insertion of an In-Space interspinous spacer is an effective and safe method of dynamic stabilization not accompanied by any serious complications.
- ODI improved by 63% 6 months after surgery with a decrease in this effect 12 months after surgery. VAS for axial and radicular pain, as reported by patients, improved on average by 55.4% 6 months and by 57.8% 12 months after surgery.
- In all cases, the lordotic sagittal angle remained after surgery and the extent of segmental motion from flexion to extension was minimally changed.
Key words:
lumbar spinal stenosis – neurogenic intermittent claudication – interspinous process device – spacer
Zdroje
1. Mayer HM, Korge A. Microsurgical decompression of degenerative lumbar spinal stenosis. Eur Spine J 2009;18:1989–1990.
2. Mardjetko SM, Connolly PJ, Shott S.Degenerative lumbar spondylolisthesis: a meta-analysis of literature 1970–1993. Spine (Suppl) 1994;19:2256–2265.
3. Lazaro BCR, Brasiliense LBC, Sawa AGU, Reyes PM, Theodore N, Sonntag VKH, at al. Biomechanics of a novel minimally invasive lumbar interspinous spacer: effects on kinematics, facet loads, and foraminal height. Neurosurgery 2010;66:126–133.
4. Richards,JC, Majumdar S, Lindsey DP, Beaupré GS, Yerby SA. The treatment mechanism of an interspinous process implant for lumbar neurogenic intermittent claudication. Spine 2005;30: 744–749.
5. Adamus M, Herold I, Trenkler Š, Koutná J, Kropáč A, Závada J. Klasifikace fyzického stavu nemocného podle ASA – dozrál čas na změnu? Anest intenziv Med 2007;18:9–23.
6. Carlsson AM. Assessment of chronic pain: I. Aspects of the reliability and validity of the visual analogue scale. Pain 1983;16:87–101.
7. Fairbank JCT, Pynsent PB. The Oswestry Disability Index. Spine 2000;25:2940–8.
8. Collignon F, Fransen P. Treatment of symptomatic degenerative lumbar spinal stenosis by a percutaneous stand-alone lumbar interspinous implant. Preliminary experience with the Aperius device. Neurochirurgie 2010;56:3–7.
9. Nardi P, Cabezas D, Rea G, Pettorini BL. Aperius PercLID stand alone interspinous system for the treatment of degenerative lumbar stenosis: experience on 152 cases. J Spinal Disord Tech 2010;23:203–207.
10. Siddiqui M, Karadimas E, Nicol M, Smith FW, Wardlaw D. Influence of X Stop on neural foramina and spinal canal area in spinal stenosis. Spine 2006;31:2958–2962.
11. Sobottke R, Schlutter-Brust K, Kaulhausen T, Rollinghoff M, Joswig B, Stutzer H, at al. Interspinous implants (X Stop, Wallis, Diam) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome? Eur Spine J 2009;18(10):1494–1503.
12. Hrabálek L, Novotný J, Koluchová J, Vaverka M, Kalita O, Langová K. Změny parametrů páteře po implantaci bederní interspinózní rozpěrky DIAM. Cesk Slov Neurol N 2009;72, 105:337–342.
13. Zucherman JF, Hsu KY, Hartjen ChA, Mehalic TF, Implicite DA, Martin MJ, at al. A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results. Eur Spine J 2004;13:22–31.
14. Zucherman JF, Hsu KY, Hartjen ChA, Mehalic TF, Implicite DA, Martin MJ, at al. A multicenter, prospective, randomized trial evaluation the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication. Spine, 2005;30:1351–1358.
15. Kuchta J, Sobottke R, Eysel P, Simons P. Two-year results of interspinous spacer (X-Stop) implantation in 175 patients with neurologic intermittent claudication due to lumbar spinal stenosis. Eur Spine J 2009;18:823–829.
16. Rolfe KW, Zucherman JF, Kondrashov DG, Hsu KY, Nosova E. Scoliosis and interspinous decompression with the X-STOP: prospective minimum 1-year outcomes in lumbar spinal stenosis. Spine J 2010;10(11):972–978.
17. Brussee P, Hauth J, Donk RD, Verbeek ALM, Bartels RHMA. Self-rated evaluation of outcome of the implantation of interspinous process distraction (X-Stop) for neurogenic claudication. Eur Spine J 2008;17:200–203.
18. Verhoof OJ, Bron JL, Wapstra FH, Royen BJ. High failure rate of the interspinous distraction device (X-Stop) for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis. Eur Spine J 2008;17:188.
19. Mayer HM, Zentz F, Siepe C, Korge A.Percutaneous interspinous distraction for the treatment of dynamic lumbar spinal stenosis and low back pain. Oper Orthop Traumatol 2010;22:495–511.
20. Barbagallo GM, Olindo G, Corbino L, Albanese V. Analysis of complications in patients treated with the X-Stop Interspinous Process Decompression System: proposal for a novel anatomic scoring system for patient selection and review of the literature. Neurosurgery 2009;65:111–119.
21. Barbagallo GM, Corbino LA, Olindo G, Foti P, Albanese V, Signorelli F. The „sandwich phenomenon“: a rare complication in adjacent, double-level X-stop surgery: report of three cases and review of the literature. Spine 2010;35:E96–100.
22. Chung KJ, Hwang YS, Koh SH. Stress fracture of bilateral posterior facet after insertion of interspinous implant. Spine 2009;34:E380–383.
23. Miller JD, Miller MC, Lucas MG. Erosion of the spinous process: a potential cause of interspinous process spacer failure. J Neurosurg Spine 2010;12:210–213.
Štítky
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