Minim Invasive Neurosurg 2010; 53(4): 179-183
DOI: 10.1055/s-0030-1263108
Original Article

© Georg Thieme Verlag KG Stuttgart · New York

Clinical Outcomes and Quality of Life 1 Year after Open Microsurgical Decompression or Implantation of an Interspinous Stand-Alone Spacer

R. Sobottke1 , M. Röllinghoff1 , J. Siewe1 , U. Schlegel1 , A. Yagdiran1 , M. Spangenberg1 , R. Lesch1 , P. Eysel1 , T. Koy1
  • 1Department of Orthopaedic and Trauma Surgery, University of Cologne, Cologne, Germany
Weitere Informationen


03. Dezember 2010 (online)


Background: Interspinous stand-alone implants are inserted without open decompression to treat symptomatic lumbar spinal stenosis (LSS). The insertion procedure is technically simple, low-risk, and quick. However, the question remains whether the resulting clinical outcomes compare with those of microsurgical decompression, the gold standard.

Material and Methods: This prospective, comparative study included all patients (n=36) with neurogenic intermittent claudication (NIC) secondary to LSS with symptoms improving in forward flexion treated operatively with either interspinous stand-alone spacer insertion (Aperius®; Medtronic, Tolochenaz, Switzerland) (group1) or microsurgical bilateral operative decompression (group 2) between February 2007 and November 2008. Data (patient data, operative data, COMI, SF-36 PCS and MCS, ODI, and walking tolerance) were collected preoperatively as well as at 6 weeks, at 3, 6, and 9 months, and at one year follow-up (FU). All patients had complete FU over 1 year.

Results: Compared to preoperative measurements, surgery led to improvements of all parameters in the entire collective as well as both individual groups. There were no statistically relevant differences between the 2 groups over the entire course of FU. However, improvements in the ODI and SF-36 MCS were not significant in group 1, in contrast to those of group 2. Also, although in group 1 the improvements in leg pain (VAS leg) were still significant (p<0.05) at 6 months, this was no longer the case at 1 year FU. In group 1 at 1 year FU an increase in leg pain was observed, while in group 2 minimal improvements continued. Walking tolerance was significantly improved at all FU times compared to preoperatively, regardless of group (p<0.01). At no time there was a significant difference between the groups. In group 1, admission and operative times were shorter and blood loss decreased. The complication rate was 0% in group 1 and 20% in group 2, however reoperation was required by 27.3% of group 1 patients and 0% of group 2.

Conclusion: Implantation of an interspinous stand-alone spacer yields clinical success comparable to open decompression, at least within the first year of FU. The 1-year conversion rate of 27.3% is, however, decidedly too high.


  • 1 Vogt MT, Cawthon PM, Kang JD. et al . Prevalence of symptoms of cervical and lumbar stenosis among participants in the Osteoporotic Fractures in Men Study.  Spine. 2006;  31 1445-1451
  • 2 Guralnik JM, Ferrucci L, Simonsick EM. et al . Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability.  New Engl J Med. 1995;  332 556-561
  • 3 Kim KA, McDonald M, Pik JH. et al . Dynamic intraspinous spacer technology for posterior stabilization: case-control study on the safety, sagittal angulation, and pain outcome at 1-year follow-up evaluation.  Neurosurgical focus. 2007;  22 E7
  • 4 Richards JC, Majumdar S, Lindsey DP. et al . The treatment mechanism of an interspinous process implant for lumbar neurogenic intermittent claudication.  Spine. 2005;  30 744-749
  • 5 Siddiqui M, Smith FW, Wardlaw D. One-year results of X Stop interspinous implant for the treatment of lumbar spinal stenosis.  Spine. 2007;  32 1345-1348
  • 6 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. 2006;  4 463-471
  • 7 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 1351-1358
  • 8 Roder C, Chavanne A, Mannion AF. et al . SSE Spine Tango – content, workflow, set-up. Tango Eur Spine J. 2005;  14 920-924
  • 9 Mannion AF, Denzler R, Dvorak J. et al . A randomised controlled trial of post-operative rehabilitation after surgical decompression of the lumbar spine.  Eur Spine J. 2007;  16 1101-1117
  • 10 Amundsen T, Weber H, Nordal HJ. et al . Lumbar spinal stenosis: conservative or surgical management?: A prospective 10-year study.  Spine (Phila Pa 1976). 2000;  25 1424-1435 ; discussion 1435–1426
  • 11 Malmivaara A, Slatis P, Heliovaara M. et al . Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial.  Spine (Phila Pa 1976). 2007;  32 1-8
  • 12 Weinstein JN, Tosteson TD, Lurie JD. et al . Surgical versus nonsurgical therapy for lumbar spinal stenosis.  New Engl J Med. 2008;  358 794-810
  • 13 Richter A, Schutz C, Hauck M. et al . Does an interspinous device (Coflex) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients.  Eur Spine J. 2009; 
  • 14 Wild MH, Glees M, Plieschnegger C. et al . Five-year follow-up examination after purely minimally invasive posterior stabilization of thoracolumbar fractures: a comparison of minimally invasive percutaneously and conventionally open treated patients.  Arch Orthopaed Trauma Surg. 2007;  127 335-343
  • 15 Deyo RA, Mirza SK. Trends and variations in the use of spine surgery.  Clin Orthopaed Related Res. 2006;  443 139-146
  • 16 Ragab AA, Fye MA, Bohlman HH. Surgery of the lumbar spine for spinal stenosis in 118 patients 70 years of age or older.  Spine. 2003;  28 348-353
  • 17 Silvers HR, Lewis PJ, Asch HL. Decompressive lumbar laminectomy for spinal stenosis.  J Neurosurg. 1993;  78 695-701
  • 18 Thome C, Zevgaridis D, Leheta O. et al . Outcome after less-invasive decompression of lumbar spinal stenosis: a randomized comparison of unilateral laminotomy, bilateral laminotomy, and laminectomy.  J Neurosurg. 2005;  3 129-141
  • 19 Wang MY, Green BA, Shah S. et al . Complications associated with lumbar stenosis surgery in patients older than 75 years of age.  Neurosurgical focus. 2003;  14 e7
  • 20 Jonsson B, Annertz M, Sjoberg C. et al . A prospective and consecutive study of surgically treated lumbar spinal stenosis. Part II: Five-year follow-up by an independent observer.  Spine. 1997;  22 2938-2944
  • 21 Malter AD, McNeney B, Loeser JD. et al . 5-year reoperation rates after different types of lumbar spine surgery.  Spine. 1998;  23 814-820
  • 22 Martin BI, Mirza SK, Comstock BA. et al . Are lumbar spine reoperation rates falling with greater use of fusion surgery and new surgical technology?.  Spine. 2007;  32 2119-2126
  • 23 Arinzon Z, Adunsky A, Fidelman Z. et al . Outcomes of decompression surgery for lumbar spinal stenosis in elderly diabetic patients.  Eur Spine J. 2004;  13 32-37
  • 24 Cornefjord M, Byrod G, Brisby H. et al . A long-term (4- to 12-year) follow-up study of surgical treatment of lumbar spinal stenosis.  Eur Spine J. 2000;  9 563-570
  • 25 Delank KS, Eysel P, Zollner J. et al . Undercutting decompression versus laminectomy. Clinical and radiological results of a prospective controlled trial.  Der Orthopade. 2002;  31 1048-1056 ; discussion 1057
  • 26 Galiano K, Obwegeser AA, Gabl MV. et al . Long-term outcome of laminectomy for spinal stenosis in octogenarians.  Spine. 2005;  30 332-335
  • 27 Rosen DS, O’Toole JE, Eichholz KM. et al . Minimally invasive lumbar spinal decompression in the elderly: outcomes of 50 patients aged 75 years and older.  Neurosurgery. 2007;  60 503-509 ; discussion 509–510
  • 28 Sanderson PL, Wood PL. Surgery for lumbar spinal stenosis in old people.  J Bone Joint Surg. 1993;  75 393-397
  • 29 Shabat S, Arinzon Z, Folman Y. et al . Long-term outcome of decompressive surgery for lumbar spinal stenosis in octogenarians.  Eur Spine J. 2008;  17 193-198


R. SobottkeMD 

Department of Orthopaedic

and Trauma Surgery

University of Cologne

Joseph-Stelzmann-Straße 9

50939 Cologne


Telefon: +49/221/478 4616

Fax: +49/221/478 86731