Skip to main content
Top
Published in: BMC Musculoskeletal Disorders 1/2015

Open Access 01-12-2015 | Research article

Interspinous process stabilization with Rocker via unilateral approach versus X-Stop via bilateral approach for lumbar spinal stenosis: a comparative study

Authors: Weimin Huang, Zhengqi Chang, Jingtao Zhang, Ruoxian Song, Xiuchun Yu

Published in: BMC Musculoskeletal Disorders | Issue 1/2015

Login to get access

Abstract

Background

Rocker is a novel interspinous process stabilization (IPS) that can be installed via unilateral approach by virtue of its unique design. This controlled study compared the clinical outcome of Rocker versus X-Stop to access the feasibility and validity of the novel IPS.

Methods

From March 2011 to September 2012, 32 patients treated with Rocker and 30 patients treated with X-Stop were enrolled in this study. The primary clinical outcome measure was Oswestry Disability Index (ODI) score. The secondary clinical outcome measure was Japanese orthopaedics association (JOA) score. Disc height index (DHI) and foraminal height index (FHI) were measured for postoperative radiographic evaluation. Implant failures were also recorded.

Results

There were 55 patients with complete data during 24 months follow-up. Among the 55 patients, 38 patients underwent IPS in combination with microdecompression. At the final follow-up, 49 patients achieved a minimal clinical important difference (≥8 points ODI improvement). The mean operative time was 53.6 min (range, 30 to 90 min) in Rocker group and 63.1 min (range, 30 to 100 min) in X-Stop group. The average blood loss was 111 ml (range, 50 to 400 ml) in Rocker group and 138 ml (range, 50 to 350 ml) in X-Stop group. ODI score were significantly improved from preoperative 46.8 ± 9.2 to 12.2 ± 2.6 at 24 months follow-up in the Rocker group and from preoperative 45.8 ± 9.8 to 11.8 ± 2.4 at 24 months follow-up in the X-Stop group. JOA score also improved significantly in both groups. The radiographic parameters of DHI and FHI in both groups increased immediately postoperatively, however, the improvements seemed to revert toward initial value during follow-up. Two patients in Rocker group demonstrated implant dislocation within one week postoperatively and one patient in X-Stop group demonstrated implant migration at two months postoperatively.

Conclusions

Preliminary clinical and radiographic outcome was similar between Rocker and X-Stop group. For patients of lumbar spinal stenosis with unilateral nerve root involved or mild-to-moderate central canal stenosis, Rocker offers a new alternative with less damage.
Literature
1.
go back to reference Ishimoto Y, Yoshimura N, Muraki S, Yamada H, Nagata K, Hashizume H, et al. Associations between radiographic lumbar spinal stenosis and clinical symptoms in the general population: the Wakayama Spine Study. Osteoarthr Cartilage. 2013;21:783–8.CrossRef Ishimoto Y, Yoshimura N, Muraki S, Yamada H, Nagata K, Hashizume H, et al. Associations between radiographic lumbar spinal stenosis and clinical symptoms in the general population: the Wakayama Spine Study. Osteoarthr Cartilage. 2013;21:783–8.CrossRef
2.
go back to reference Hasegawa T, An HS, Haughton VM, Nowicki BH. Lumbar foraminal stenosis: critical heights of the intervertebral discs and foramina. A cryomicrotome study in cadavera. J Bone Joint Surg Am. 1995;77:32–8.PubMed Hasegawa T, An HS, Haughton VM, Nowicki BH. Lumbar foraminal stenosis: critical heights of the intervertebral discs and foramina. A cryomicrotome study in cadavera. J Bone Joint Surg Am. 1995;77:32–8.PubMed
3.
go back to reference Yoshida M, Shima K, Taniguchi Y, Tamaki T, Tanaka T. Hypertrophied ligamentum flavum in lumbar spinal canal stenosis. Pathogenesis and morphologic and immunohistochemical observation. Spine (Phila Pa 1976). 1992;17:1353–60.CrossRef Yoshida M, Shima K, Taniguchi Y, Tamaki T, Tanaka T. Hypertrophied ligamentum flavum in lumbar spinal canal stenosis. Pathogenesis and morphologic and immunohistochemical observation. Spine (Phila Pa 1976). 1992;17:1353–60.CrossRef
4.
go back to reference Kovacs FM, Urrutia G, Alarcon JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976). 2011;36:E1335–51.CrossRef Kovacs FM, Urrutia G, Alarcon JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976). 2011;36:E1335–51.CrossRef
5.
go back to reference Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008;358:794–810.CrossRefPubMedPubMedCentral Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008;358:794–810.CrossRefPubMedPubMedCentral
6.
go back to reference Grasso G, Giambartino F, Iacopino DG. Clinical analysis following lumbar interspinous devices implant: where we are and where we go. Spinal Cord. 2014;52:740–3.CrossRefPubMed Grasso G, Giambartino F, Iacopino DG. Clinical analysis following lumbar interspinous devices implant: where we are and where we go. Spinal Cord. 2014;52:740–3.CrossRefPubMed
7.
go back to reference Gazzeri R, Galarza M, Alfieri A. Controversies about interspinous process devices in the treatment of degenerative lumbar spine diseases: past, present, and future. Biomed Res Int. 2014;2014:975052.CrossRefPubMedPubMedCentral Gazzeri R, Galarza M, Alfieri A. Controversies about interspinous process devices in the treatment of degenerative lumbar spine diseases: past, present, and future. Biomed Res Int. 2014;2014:975052.CrossRefPubMedPubMedCentral
8.
go back to reference Stromqvist BH, Berg S, Gerdhem P, Johnsson R, Moller A, Sahlstrand T, et al. X-Stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-year follow-up. Spine (Phila Pa 1976). 2013;38:1436–42.CrossRef Stromqvist BH, Berg S, Gerdhem P, Johnsson R, Moller A, Sahlstrand T, et al. X-Stop versus decompressive surgery for lumbar neurogenic intermittent claudication: randomized controlled trial with 2-year follow-up. Spine (Phila Pa 1976). 2013;38:1436–42.CrossRef
9.
go back to reference Lonne G, Johnsen LG, Rossvoll I, Andresen H, Storheim K, Zwart JA, et al. Minimally invasive decompression versus X-Stop in lumbar spinal stenosis: a randomized controlled multicenter study. Spine (Phila Pa 1976). 2015;40:77–85.CrossRef Lonne G, Johnsen LG, Rossvoll I, Andresen H, Storheim K, Zwart JA, et al. Minimally invasive decompression versus X-Stop in lumbar spinal stenosis: a randomized controlled multicenter study. Spine (Phila Pa 1976). 2015;40:77–85.CrossRef
10.
go back to reference Fuchs PD, Lindsey DP, Hsu KY, Zucherman JF, Yerby SA. The use of an interspinous implant in conjunction with a graded facetectomy procedure. Spine (Phila Pa 1976). 2005;30:1266–72.CrossRef Fuchs PD, Lindsey DP, Hsu KY, Zucherman JF, Yerby SA. The use of an interspinous implant in conjunction with a graded facetectomy procedure. Spine (Phila Pa 1976). 2005;30:1266–72.CrossRef
11.
go back to reference Ploumis A, Christodoulou P, Kapoutsis D, Gelalis I, Vraggalas V, Beris A. Surgical treatment of lumbar spinal stenosis with microdecompression and interspinous distraction device insertion. A case series. J Orthop Surg Res. 2012;7:35.CrossRefPubMedPubMedCentral Ploumis A, Christodoulou P, Kapoutsis D, Gelalis I, Vraggalas V, Beris A. Surgical treatment of lumbar spinal stenosis with microdecompression and interspinous distraction device insertion. A case series. J Orthop Surg Res. 2012;7:35.CrossRefPubMedPubMedCentral
12.
go back to reference Puzzilli F, Gazzeri R, Galarza M, Neroni M, Panagiotopoulos K, Bolognini A, et al. Interspinous spacer decompression (X-STOP) for lumbar spinal stenosis and degenerative disk disease: a multicenter study with a minimum 3-year follow-up. Clin Neurol and Neurosur. 2014;124:166–74.CrossRef Puzzilli F, Gazzeri R, Galarza M, Neroni M, Panagiotopoulos K, Bolognini A, et al. Interspinous spacer decompression (X-STOP) for lumbar spinal stenosis and degenerative disk disease: a multicenter study with a minimum 3-year follow-up. Clin Neurol and Neurosur. 2014;124:166–74.CrossRef
13.
go back to reference 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;18:823–9.CrossRefPubMedPubMedCentral 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;18:823–9.CrossRefPubMedPubMedCentral
14.
go back to reference Siddiqui M, Smith FW, Wardlaw D. One-year results of X STOP interspinous implant for the treatment of lumbar spinal stenosis. Spine. 2007;32:1345–8.CrossRefPubMed Siddiqui M, Smith FW, Wardlaw D. One-year results of X STOP interspinous implant for the treatment of lumbar spinal stenosis. Spine. 2007;32:1345–8.CrossRefPubMed
15.
go back to reference Nandakumar A, Clark NA, Smith FW, Wardlaw D. Two-year results of X-Stop interspinous implant for the treatment of lumbar spinal stenosis a prospective study. J Spinal Disord Tech. 2013;26:1–7.CrossRefPubMed Nandakumar A, Clark NA, Smith FW, Wardlaw D. Two-year results of X-Stop interspinous implant for the treatment of lumbar spinal stenosis a prospective study. J Spinal Disord Tech. 2013;26:1–7.CrossRefPubMed
16.
go back to reference Hartjen CA, Resnick DK, Hsu KY, Zucherman JF, Hsu EH, Skidmore GA. Two-Year Evaluation of the X-STOP Interspinous Spacer in Different Primary Patient Populations With Neurogenic Intermittent Claudication due to Lumbar Spinal Stenosis. J Spinal Disord Tech. 2013. [Epub ahead of print] Hartjen CA, Resnick DK, Hsu KY, Zucherman JF, Hsu EH, Skidmore GA. Two-Year Evaluation of the X-STOP Interspinous Spacer in Different Primary Patient Populations With Neurogenic Intermittent Claudication due to Lumbar Spinal Stenosis. J Spinal Disord Tech. 2013. [Epub ahead of print]
17.
go back to reference Burnett MG, Stein SC, Bartels R. Cost-effectiveness of current treatment strategies for lumbar spinal stenosis: nonsurgical care, laminectomy, and X-STOP Clinical article. J Neurosurg Spine. 2010;13:39–46.CrossRefPubMed Burnett MG, Stein SC, Bartels R. Cost-effectiveness of current treatment strategies for lumbar spinal stenosis: nonsurgical care, laminectomy, and X-STOP Clinical article. J Neurosurg Spine. 2010;13:39–46.CrossRefPubMed
18.
go back to reference Patil S, Burton M, Storey C, Glenn C, Marino A, Nanda A. Evaluation of interspinous process distraction device (X-STOP) in a representative patient cohort. World Neurosurg. 2013;80:213–7.CrossRefPubMed Patil S, Burton M, Storey C, Glenn C, Marino A, Nanda A. Evaluation of interspinous process distraction device (X-STOP) in a representative patient cohort. World Neurosurg. 2013;80:213–7.CrossRefPubMed
20.
go back to reference Toth JM, Wang M, Estes BT, Scifert JL, Seim 3rd HB, Turner AS. Polyetheretherketone as a biomaterial for spinal applications. Biomaterials. 2006;27:324–34.CrossRefPubMed Toth JM, Wang M, Estes BT, Scifert JL, Seim 3rd HB, Turner AS. Polyetheretherketone as a biomaterial for spinal applications. Biomaterials. 2006;27:324–34.CrossRefPubMed
21.
go back to reference Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lonne G, et al. Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness study. BMJ. 2015;350:h1603.CrossRefPubMedPubMedCentral Nerland US, Jakola AS, Solheim O, Weber C, Rao V, Lonne G, et al. Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness study. BMJ. 2015;350:h1603.CrossRefPubMedPubMedCentral
22.
go back to reference Brox JI, Reikeras O, Nygaard O, Sorensen R, Indahl A, Holm I, et al. Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: a prospective randomized controlled study. Pain. 2006;122:145–55.CrossRefPubMed Brox JI, Reikeras O, Nygaard O, Sorensen R, Indahl A, Holm I, et al. Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: a prospective randomized controlled study. Pain. 2006;122:145–55.CrossRefPubMed
23.
go back to reference Hellum C, Johnsen LG, Storheim K, Nygaard OP, Brox JI, Rossvoll I, et al. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ. 2011;342:d2786.CrossRefPubMedPubMedCentral Hellum C, Johnsen LG, Storheim K, Nygaard OP, Brox JI, Rossvoll I, et al. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ. 2011;342:d2786.CrossRefPubMedPubMedCentral
24.
go back to reference Kim KT, Park SW, Kim YB. Disc height and segmental motion as risk factors for recurrent lumbar disc herniation. Spine (Phila Pa 1976). 2009;34:2674–8.CrossRef Kim KT, Park SW, Kim YB. Disc height and segmental motion as risk factors for recurrent lumbar disc herniation. Spine (Phila Pa 1976). 2009;34:2674–8.CrossRef
25.
go back to reference Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999–2010. JAMA. 2012;307:491–7.CrossRefPubMed Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999–2010. JAMA. 2012;307:491–7.CrossRefPubMed
26.
go back to reference Saberi H, Isfahani AV. Higher preoperative Oswestry disability Index is associated with better surgical outcome in upper lumbar disc herniations. Eur Spine J. 2008;17:117–21.CrossRefPubMed Saberi H, Isfahani AV. Higher preoperative Oswestry disability Index is associated with better surgical outcome in upper lumbar disc herniations. Eur Spine J. 2008;17:117–21.CrossRefPubMed
27.
go back to reference Lonne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Ronning R, et al. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine (Phila Pa 1976). 2015;40:514–20.CrossRef Lonne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Ronning R, et al. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine (Phila Pa 1976). 2015;40:514–20.CrossRef
28.
go back to reference Ryu SJ, Kim IS. Interspinous implant with unilateral laminotomy for bilateral decompression of degenerative lumbar spinal stenosis in elderly patients. J Korean Neurosurg S. 2010;47:338–44.CrossRef Ryu SJ, Kim IS. Interspinous implant with unilateral laminotomy for bilateral decompression of degenerative lumbar spinal stenosis in elderly patients. J Korean Neurosurg S. 2010;47:338–44.CrossRef
29.
go back to reference Zhou D, Nong LM, Du R, Gao GM, Jiang YQ, Xu NW. Effects of interspinous spacers on lumbar degenerative disease. Exp Ther Med. 2013;5:952–6.PubMedPubMedCentral Zhou D, Nong LM, Du R, Gao GM, Jiang YQ, Xu NW. Effects of interspinous spacers on lumbar degenerative disease. Exp Ther Med. 2013;5:952–6.PubMedPubMedCentral
30.
go back to reference Pan B, Zhang ZJ, Lu YS, Xu WG, Fu CD. Experience with the second-generation Wallis interspinous dynamic stabilization device implanted in degenerative lumbar disease: a case series of 50 patients. Turk Neurosurg. 2014;24:713–9.PubMed Pan B, Zhang ZJ, Lu YS, Xu WG, Fu CD. Experience with the second-generation Wallis interspinous dynamic stabilization device implanted in degenerative lumbar disease: a case series of 50 patients. Turk Neurosurg. 2014;24:713–9.PubMed
31.
go back to reference Sandu N, Schaller B, Arasho B, Orabi M. Wallis interspinous implantation to treat degenerative spinal disease: description of the method and case series. Expert Rev Neurother. 2011;11:799–807.CrossRefPubMed Sandu N, Schaller B, Arasho B, Orabi M. Wallis interspinous implantation to treat degenerative spinal disease: description of the method and case series. Expert Rev Neurother. 2011;11:799–807.CrossRefPubMed
32.
go back to reference Barz T, Lange J, Melloh M, Staub LP, Merk HR, Kloting I, et al. Histomorphometric and radiographical changes after lumbar implantation of the PEEK nonfusion interspinous device in the BB.4S rat model. Spine. 2013;38:E263–9.CrossRefPubMed Barz T, Lange J, Melloh M, Staub LP, Merk HR, Kloting I, et al. Histomorphometric and radiographical changes after lumbar implantation of the PEEK nonfusion interspinous device in the BB.4S rat model. Spine. 2013;38:E263–9.CrossRefPubMed
33.
go back to reference Sobottke R, Schluter-Brust K, Kaulhausen T, Rollinghoff M, Joswig B, Stutzer H, et al. Interspinous implants (X Stop (R), Wallis (R), Diam (R)) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome?Eur. Spine J. 2009;18:1494–503.CrossRef Sobottke R, Schluter-Brust K, Kaulhausen T, Rollinghoff M, Joswig B, Stutzer H, et al. Interspinous implants (X Stop (R), Wallis (R), Diam (R)) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome?Eur. Spine J. 2009;18:1494–503.CrossRef
34.
go back to reference Sihvonen T, Herno A, Paljarvi L, Airaksinen O, Partanen J, Tapaninaho A. Local denervation atrophy of paraspinal muscles in postoperative failed back syndrome. Spine (Phila Pa 1976). 1993;18:575–81.CrossRef Sihvonen T, Herno A, Paljarvi L, Airaksinen O, Partanen J, Tapaninaho A. Local denervation atrophy of paraspinal muscles in postoperative failed back syndrome. Spine (Phila Pa 1976). 1993;18:575–81.CrossRef
35.
go back to reference Gejo R, Matsui H, Kawaguchi Y, Ishihara H, Tsuji H. Serial changes in trunk muscle performance after posterior lumbar surgery. Spine (Phila Pa 1976). 1999;24:1023–8.CrossRef Gejo R, Matsui H, Kawaguchi Y, Ishihara H, Tsuji H. Serial changes in trunk muscle performance after posterior lumbar surgery. Spine (Phila Pa 1976). 1999;24:1023–8.CrossRef
36.
go back to reference Fujiwara A, Kobayashi N, Saiki K, Kitagawa T, Tamai K, Saotome K. Association of the Japanese Orthopaedic Association score with the Oswestry Disability Index, Roland-Morris Disability Questionnaire, and short-form 36. Spine (Phila Pa 1976). 2003;28:1601–7. Fujiwara A, Kobayashi N, Saiki K, Kitagawa T, Tamai K, Saotome K. Association of the Japanese Orthopaedic Association score with the Oswestry Disability Index, Roland-Morris Disability Questionnaire, and short-form 36. Spine (Phila Pa 1976). 2003;28:1601–7.
Metadata
Title
Interspinous process stabilization with Rocker via unilateral approach versus X-Stop via bilateral approach for lumbar spinal stenosis: a comparative study
Authors
Weimin Huang
Zhengqi Chang
Jingtao Zhang
Ruoxian Song
Xiuchun Yu
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2015
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/s12891-015-0786-9

Other articles of this Issue 1/2015

BMC Musculoskeletal Disorders 1/2015 Go to the issue