Clinical and biomechanical research supporting the X-STOP Spacer

Substantial scientific research has been conducted and shows that the X-STOP Spacer can perform safely and effectively in patients with LSS. Prior to research on patients, numerous laboratory studies of biomechanics were also carried out to answer questions regarding the durability of the X-STOP Spacer and its effect on the human spine.

Since 2002, there have been several scientific papers and reviews published in major medical journals from around the world describing these research findings for the X-STOP Spacer. In addition, more than 50 peer-reviewed abstracts have been accepted and displayed at scientific spine meetings worldwide.

The following directory lists published clinical research and reviews as well as published biomechanical research by year. Please note: clinical studies involve patients, while biomechanical studies do not.

2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002

2008
Published clinical research and reviews

Brussee P, Hauth J, Donk RD, Verbeek AL, Bartels RH. Self-rated evaluation of outcome of the implantation of interspinous process distraction (X-Stop) for neurogenic claudication. Eur Spine J. 2008;17(2):200-203.

2007
Published clinical research and reviews

Bono CM, Vaccaro AR. Interspinous process devices in the lumbar spine. J Spinal Disord Tech. 2007;20(3):255-261.

†*Kim DH, Albert TJ. Interspinous process spacers. J Am Acad Orthop Surg. 2007;15(4):200-2007.

†*Kondrashov DG, Hannibal M, Hsu KY, Zucherman JF. X STOP versus decompression for neurogenic claudication: economic and clinical analysis. The Internet Journal of Minimally Invasive Spinal Technology. 2007. Volume 1, number 2.

†*Lauryssen C. Appropriate selection of patients with lumbar spinal stenosis for interspinous process decompression with the X STOP device. Neurosurg Focus. 2007;22(1):1-7.

†*Siddiqui M, Smith FW, Wardlaw D. One-year results of X Stop interspinous implant for the treatment of lumbar spinal stenosis. Spine. 2007;32(12):1345-1348.

2006
Published clinical research and reviews

†*Anderson PA, *Tribus CB, Kitchel SH. Treatment of neurogenic claudication by interspinous decompression: application of the X-STOP device in patients with lumbar degenerative spondylolisthesis. J Neurosurg Spine. 2006;4(6):463-471.

†*Chiu JC. Interspinous process decompression (IPD) system (X-STOP) for the treatment of lumbar spinal stenosis. Surg Technol Int. 2006;15:265-275 (www.ump.com).

Eicholz KM, Fessler RG. Is the X STOP interspinous implant a safe and effective treatment for neurogenic intermittent claudication? Nat Clin Pract Neurol. 2006;2(1):22-23.

†*Fokter SK, *Yerby SA. Patient-based outcomes for the operative treatment of degenerative lumbar spinal stenosis. Eur Spine J. 2006;15(11):1661-1669. Epub 2005 Dec 21.

†*Hsu KY, *Zucherman JF, Hartjen CA, et al. Quality of life of lumbar spinal stenosis-treated patients in whom the X STOP interspinous device was implanted. J Neurosurg Spine. 2006;5:500-507.

†*Kondrashov DG, Hannibal M, *Hsu KY, et al. Interspinous process decompression with the X-STOP device for lumbar spinal stenosis: a 4-year follow-up study. J Spinal Disord Tech. 2006;19(5):323-327.

†*Siddiqui M, Karadimas E, Nicol M, et al. Effects of X-stop device on sagittal lumbar spine kinematics in spinal stenosis. J Spinal Disord Tech. 2006;19(5):328-333.

†*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(25):2958-2962.

Published biomechanical research

†*Talwar V, et al. Insertion loads of the X-STOP interspinous process distraction system designed to treat neurogenic intermittent claudication. Eur Spine J. 2006;15(6):908-912. Epub 2005 May 31.

2005
Published clinical research and reviews

Christie SD, Song JK, Fessler RG. Dynamic interspinous process technology. Spine. 2005;30(16 Suppl):S73-S78.

*Siddiqui M, Nicol M, Karadimas E, et al. The positional magnetic resonance imaging changes in the lumbar spine following insertion of a novel interspinous process distraction device. Spine. 2005;30(23):2677-2682.

Thunder R, *Hsu KY, *Zucherman JF. The X-stop interspinous process decompression system for the treatment of lumbar neurogenic claudication. In: Kim DH, Cammisa FP Jr, Fessler RG, eds. Dynamic Reconstruction of the Spine. New York, NY: Thieme Medical Publishers; 2005, chapter 32.

*Zucherman JF, Silverman J. Managing spinal conditions in older persons. J Musculoskel Med. 2005;22:214-222.

†*Zucherman JF, *Hsu KY, Hartjen CA, et al. 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. 2005; 30(12):1351-1358.

Published biomechanical research

†*Fuchs PD, *Lindsey DP, *Hsu KY, et al. The use of an interspinous implant in conjunction with a graded facetectomy procedure. Spine. 2005;30(11):1266-1272; discussion 1273-1274.

†*Richards JC, *Majumdar S, *Lindsey DP, et al. The treatment mechanism of an interspinous process implant for lumbar neurogenic intermittent claudication. Spine. 2005;30(7):744-749.

*Wiseman CM, *Lindsey DP, *Fredrick AD, et al. The effect of an interspinous process implant on facet loading during extension. Spine. 2005;30(8):903-907.

2004
Published clinical research and reviews

Gunzburg R, Szpalski M. Lumbar spinal stenosis: clinical features and new trends in surgical treatment. Geriatric Times. 2004;5(4):11-13.

Heijnen S, Kramer F. Spinal distraction as therapy for lumbar spinal stenosis - the first results. Dutch Orthopedic Journal [Nederlands Tijdschrift voor Orthopaedie]. 2004;11(4):199-203.

Lee J, Hida K, Seki T, et al. An interspinous process distractor (X-STOP) for lumbar spinal stenosis in elderly patients: preliminary experiences in 10 consecutive cases. J of Spinal Disord Tech. 2004;17(1):72-77; discussion 78.

†*Zucherman JF, *Hsu KY, *Hartjen CA, et al. A prospective randomized multicenter study for the treatment of lumbar spinal stenosis with the X-STOP interspinous implant: one-year results. Eur Spine J. 2004;13(1):22-31. Epub 2003 Dec 19.

2003
Published clinical review

Gunzburg R, Szpalski M. The conservative surgical treatment of lumbar spinal stenosis in the elderly. Eur Spine J. 2003;12(2 Suppl):S176-180.

Published biomechanical research

†*Lindsey DP, *Swanson KE, *Fuchs P, et al. The effects of an interspinous implant on the kinematics of the instrumented and adjacent levels in the lumbar spine. Spine. 2003;28(19):2192-2197.

†*Swanson KE, *Lindsey DP, *Hsu KY, et al. The effects of an interspinous implant on intervertebral disc pressures. Spine. 2003;28(1):26-32.

2002
Peer-reviewed clinical abstracts

Mehalic T. Treatment of spinal stenosis with an interspinous spacer. Proceedings of the AANS/CNS Section: Spine and Peripheral Nerves; 2002; Orlando, FL.

*Zucherman JF, et al. Multicenter randomized prospective trial for treatment of lumbar neurogenic claudication with an interspinous device: one-year results. Proceedings of the International Meeting on Advanced Spine Techniques; 2002; Montreux, Switzerland.

*Zucherman JF, et al. Multicenter randomized prospective trial for treatment of lumbar neurogenic claudication with an interspinous device: one-year results. Proceedings of the International Society for the Study of the Lumbar Spine; 2002; Cleveland, OH.

*Zucherman J, Hsu KY, Glassman J. A prospective randomized clinical trial for the treatment of lumbar spinal stenosis with an interspinous spacer. Proceedings of the American Academy of Physical Medicine and Rehabilitation; 2002; Orlando, FL.

*Zucherman JF, et al. Treatment of lumbar spinal stenosis with an interspinous spacer. Proceedings of Eurospine; 2002; Nantes, France.

*Zucherman JF, et al. Treatment of lumbar spinal stenosis with an interspinous spacer. Proceedings of the North American Spine Society; 2002; Montreal, Canada.

Disclosure

An asterisk (*) indicates that some or all of the authors are (or were) paid consultants of Medtronic. A cross (†) indicates that the research was sponsored in part or in whole by Medtronic.