Skip to main content
SpringerLink
Log in

A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results

European Spine Journal Aims and scope Submit manuscript

Cite this article

Abstract

Patients suffering from neurogenic intermittent claudication secondary to lumbar spinal stenosis have historically been limited to a choice between a decompressive laminectomy with or without fusion or a regimen of non-operative therapies. The X STOP Interspinous Process Distraction System (St. Francis Medical Technologies, Concord, Calif.), a new interspinous implant for patients whose symptoms are exacerbated in extension and relieved in flexion, has been available in Europe since June 2002. This study reports the results from a prospective, randomized trial of the X STOP conducted at nine centers in the U.S. Two hundred patients were enrolled in the study and 191 were treated; 100 received the X STOP and 91 received non-operative therapy (NON OP) as a control. The Zurich Claudication Questionnaire (ZCQ) was the primary outcomes measurement. Validated for lumbar spinal stenosis patients, the ZCQ measures physical function, symptom severity, and patient satisfaction. Patients completed the ZCQ upon enrollment and at follow-up periods of 6 weeks, 6 months, and 1 year. Using the ZCQ criteria, at 6 weeks the success rate was 52% for X STOP patients and 10% for NON OP patients. At 6 months, the success rates were 52 and 9%, respectively, and at 1 year, 59 and 12%. The results of this prospective study indicate that the X STOP offers a significant improvement over non-operative therapies at 1 year with a success rate comparable to published reports for decompressive laminectomy, but with considerably lower morbidity.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3 A
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8
Fig. 9

Similar content being viewed by others

References

  1. Amundsen TH, Weber F (1995) Lumbar spinal stenosis. Clinical and radiologic features. Spine 20:1178–1186

    CAS  PubMed  Google Scholar 

  2. Amundsen TH, Weber HJ et al. (2000) Lumbar spinal stenosis: conservative or surgical management? A prospective 10-year study. Spine 25:1424–1436

    CAS  PubMed  Google Scholar 

  3. Arbit E, Pannullo S (2001) Lumbar stenosis: a clinical review. Clin Orthop 384:137–143

    PubMed  Google Scholar 

  4. Benz RJ, Ibrahim ZG, Afshar P et al. (2001) Predicting complications in elderly patients undergoing lumbar decompression. Clin Orthop 384:116–121

    PubMed  Google Scholar 

  5. Blau JN, Logue V (1978) The natural history of intermittent claudication of the cauda equina. A long term follow-up study. Brain 101:211–222

    CAS  PubMed  Google Scholar 

  6. Caserta S, La Maida GA, Misaggi B et al. (2002) Elastic stabilization alone or combined with rigid fusion in spinal surgery: a biomechanical study and clinical experience based on 82 cases. Eur Spine J 11 (Suppl 2):S192–S197

    PubMed  Google Scholar 

  7. Chung SS, Lee CS, Kim SH et al. (2000) Effect of low back posture on the morphology of the spinal canal. Skeletal Radiol 29:217–223

    Article  CAS  PubMed  Google Scholar 

  8. Ciric I, Mikhael MA, Tarkington JA et al. (1980) The lateral recess syndrome. A variant of spinal stenosis. J Neurosurg 53:433–443

    CAS  PubMed  Google Scholar 

  9. Deo S, Wanders L, Makan P et al. (1998) Outcome measures for neurogenic claudication. North American Spine Society, San Francisco

  10. Dong G, Porter RW (1989) Walking and cycling tests in neurogenic and intermittent claudication. Spine 14:965–969

    CAS  PubMed  Google Scholar 

  11. Dyck P (1979) The stoop-test in lumbar entrapment radiculopathy. Spine 4:89–92

    CAS  PubMed  Google Scholar 

  12. Dyck P, Doyle JB Jr (1977) “Bicycle test” of van Gelderen in diagnosis of intermittent cauda equina compression syndrome. Case report. J Neurosurg 46:667–670

    CAS  PubMed  Google Scholar 

  13. Fritz JM, Delitto A, Welch WC et al. (1998) Lumbar spinal stenosis: a review of current concepts in evaluation, management, and outcome measurements. Arch Phys Med Rehabil 79:700–708

    CAS  PubMed  Google Scholar 

  14. Fujiwara A, An HS, Lim TH et al. (2001) Morphologic changes in the lumbar intervertebral foramen due to flexion–extension, lateral bending, and axial rotation an in vitro anatomic and biomechanical study. Spine 26:876–882

    Article  CAS  PubMed  Google Scholar 

  15. Gunzburg R, Szpalski M (2000) Lumbar spinal stenosis. Lippincott Williams and Wilkins, Philadelphia, p 414

  16. Hansraj KK, Cammisa FP Jr, O’Leary PF et al. (2001) Decompressive surgery for typical lumbar spinal stenosis. Clin Orthop 384:10–17

    PubMed  Google Scholar 

  17. Hasegawa T, An HS, Haughton VM et al. (1995) Lumbar foraminal stenosis: critical heights of the intervertebral discs and foramina. A cryomicrotome study in cadavera. J Bone Joint Surg Am 77:32–38

    CAS  PubMed  Google Scholar 

  18. Herno A, Airaksinen O, Saari T et al. (1996) Lumbar spinal stenosis: a matched-pair study of operated and non-operated patients. Br J Neurosurg 10:461–465

    Article  CAS  PubMed  Google Scholar 

  19. Hozack WJ, Rothman RH, Albert TJ et al. (1997) Relationship of total hip arthroplasty outcomes to other orthopaedic procedures. Clin Orthop 344:88–93

    PubMed  Google Scholar 

  20. Hu RW, Jaglal S, Axcell T et al. (1997) A population-based study of reoperations after back surgery. Spine 22:2265–2271

    Article  PubMed  Google Scholar 

  21. Hurri H, Slatis P, Soini J et al. (1998) Lumbar spinal stenosis: assessment of long-term outcome 12 years after operative and conservative treatment. J Spinal Disord 11:110–115

    CAS  PubMed  Google Scholar 

  22. Iguchi T, Kurihara A, Nakayama J et al. (2000) Minimum 10-year outcome of decompressive laminectomy for degenerative lumbar spinal stenosis. Spine 25:1754–1759

    Article  CAS  PubMed  Google Scholar 

  23. Inufusa A, An HS, Lim TH et al. (1996) Anatomic changes of the spinal canal and intervertebral foramen associated with flexion–extension movement. Spine 21:2412–2420

    Article  CAS  PubMed  Google Scholar 

  24. Jenis LG, An HS (2000) Spine update. Lumbar foraminal stenosis. Spine 25:389–394

    Article  CAS  PubMed  Google Scholar 

  25. Johnsson KE, Rosen I, Uden A (1992) The natural course of lumbar spinal stenosis. Clin Orthop 279:82–86

    PubMed  Google Scholar 

  26. Jonsson B, Annertz M, Sjoberg C et al. (1997) A prospective and consecutive study of surgically treated lumbar spinal stenosis. Part I: Clinical features related to radiographic findings. Spine 22:2932–2937

    Article  CAS  PubMed  Google Scholar 

  27. Jonsson B, Annertz M, Sjoberg C et al. (1997) A prospective and consecutive study of surgically treated lumbar spinal stenosis. Part II: Five-year follow-up by an independent observer. Spine 22:2938–2944

    Article  CAS  PubMed  Google Scholar 

  28. Katz JN, Lipson SJ, Larson MG et al. (1991) The outcome of decompressive laminectomy for degenerative lumbar stenosis. J Bone Joint Surg Am 73:809–816

    CAS  PubMed  Google Scholar 

  29. Katz JN, Dalgas M, Stucki G et al. (1995) Degenerative lumbar spinal stenosis. Diagnostic value of the history and physical examination. Arthritis Rheum 38:1236–1241

    CAS  PubMed  Google Scholar 

  30. Katz JN, Lipson SJ, Chang LC et al. (1996) Seven- to 10-year outcome of decompressive surgery for degenerative lumbar spinal stenosis. Spine 21:92–98

    Article  CAS  PubMed  Google Scholar 

  31. Katz JN, Stucki G, Lipson SJ et al. (1999) Predictors of surgical outcome in degenerative lumbar spinal stenosis. Spine 24:2229–2233

    Article  CAS  PubMed  Google Scholar 

  32. Kirkaldy-Willis WH, Wedge JH, Yong-Hing K et al. (1978) Pathology and pathogenesis of lumbar spondylosis and stenosis. Spine:319–328

  33. Lindsey DP, Swanson KE, Fuchs P et a. (2003) The effects of an interspinous implant on the kinematics of the instrumented and adjacent levels in the lumbar spine. Spine:2192–2197

  34. Magnaes B (1982) Clinical recording of pressure on the spinal cord and cauda equina. Part 2: Position changes in pressure on the cauda equina in central lumbar spinal stenosis. J Neurosurg 57:57–63

    CAS  PubMed  Google Scholar 

  35. Mulholland RC, Sengupta DK (2002) Rationale, principles and experimental evaluation of the concept of soft stabilization. Eur Spine J 11 (Suppl 2):S198–S205

    PubMed  Google Scholar 

  36. Onel D, Sari H, Donmez C (1993) Lumbar spinal stenosis: clinical/radiologic therapeutic evaluation in 145 patients. Conservative treatment or surgical intervention? Spine 18:291–298

    CAS  PubMed  Google Scholar 

  37. Penning L, Wilmink JT (1987) Posture-dependent bilateral compression of L4 or L5 nerve roots in facet hypertrophy. A dynamic CT-myelographic study. Spine 12:488–500

    CAS  PubMed  Google Scholar 

  38. Porter RW (1996) Spinal stenosis and neurogenic claudication. Spine 21:2046–2052

    Article  CAS  PubMed  Google Scholar 

  39. Postacchini F, Cinotti G, Perugia D et al. (1993) The surgical treatment of central lumbar stenosis. Multiple laminotomy compared with total laminectomy. J Bone Joint Surg Br 75:386–392

    CAS  PubMed  Google Scholar 

  40. Pratt RK, Fairbank JC, Virr A (2002) The reliability of the Shuttle Walking Test, the Swiss Spinal Stenosis Questionnaire, the Oxford Spinal Stenosis Score, and the Oswestry Disability Index in the assessment of patients with lumbar spinal stenosis. Spine 27:84–91

    Article  PubMed  Google Scholar 

  41. Richards J, Majumdar S, Lindsey D et al. (2002) Quantitative changes in the lumbar spinal canal with an interspinous implant. Trans Int Meeting on Advanced Spine Techniques, Montreux

  42. Saifuddin A (2000) The imaging of lumbar spinal stenosis. Clin Radiol 55:581–594

    Article  PubMed  Google Scholar 

  43. Schonstrom N, Lindahl S, Willen J et al. (1989) Dynamic changes in the dimensions of the lumbar spinal canal: an experimental study in vitro. J Orthop Res 7:115–121

    CAS  PubMed  Google Scholar 

  44. Schonstrom N, Willen J (2001) Imaging lumbar spinal stenosis. Radiol Clin North Am 39:31–53

    CAS  PubMed  Google Scholar 

  45. Senegas J (1990) La ligametoplastie intervertebrale, alternative a l’arthrodese dans le traitment des instabilities degeneratives. In: Simon L et al. (eds) La hernie discale lombaire. Masson, Paris, pp 308–315

  46. Senegas J (1991) Surgery of the intervertebral ligaments, alternative to arthrodesis in the treatment of degenerative instabilities. Acta Orthop Belg 57 (Suppl 1):221–226 [in French]

    PubMed  Google Scholar 

  47. Senegas J (2002) Mechanical supplementation by non-rigid fixation in degenerative intervertebral lumbar segments: the Wallis system. Eur Spine J 11 (Suppl 2):S164–S169

    PubMed  Google Scholar 

  48. Simotas AC (2001) Nonoperative treatment for lumbar spinal stenosis. Clin Orthop 384:153–161

    PubMed  Google Scholar 

  49. Simotas AC, Dorey FJ, Hansraj KK et al. (2000) Nonoperative treatment for lumbar spinal stenosis. Clinical and outcome results and a 3-year survivorship analysis. Spine 25:197–204

    Article  CAS  PubMed  Google Scholar 

  50. Sortland O, Magnaes B, Hauge T (1977) Functional myelography with metrizamide in the diagnosis of lumbar spinal stenosis. Acta Radiol Suppl 355:42–54

    CAS  PubMed  Google Scholar 

  51. Stoll TM, Dubois G, Schwarzenbach O (2002) The dynamic neutralization system for the spine: a multi-center study of a novel non-fusion system. Eur Spine J 11 (Suppl 2):S170–S178

    PubMed  Google Scholar 

  52. Strömqvist B, Jonsson B, Fritzell P et al. (2001) The Swedish National Register for lumbar spine surgery: Swedish Society for Spinal Surgery. Acta Orthop Scand 72:99–106

    CAS  PubMed  Google Scholar 

  53. Stucki G, Liang MH, Fossel AH et al. (1995) Relative responsiveness of condition-specific and generic health status measures in degenerative lumbar spinal stenosis. J Clin Epidemiol 48:1369–1378

    Article  CAS  PubMed  Google Scholar 

  54. Stucki G, Daltroy L, Liang MH et al. (1996) Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine 21:796–803

    Article  CAS  PubMed  Google Scholar 

  55. Swanson K, Lindsey D, Hsu K et al. (2002) The effect of an interspinous spacer on the intradiscal stress of the adjacent and treated levels. In: Trans Int Meeting on Advanced Spine Techniques, Montreux

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

    Article  PubMed  Google Scholar 

  57. Takahashi K, Hirasawa K, Unayama K (1999) Effects of walking posture, velocity and stride on neurogenic claudication: analysis with epidural pressure. In: Int Soc for the Study of the Lumabr Spine, Hawaii

  58. Turner JA, Ersek M, Herron L et al. (1992) Surgery for lumbar spinal stenosis. Attempted meta-analysis of the literature. Spine 17:1–8

    CAS  PubMed  Google Scholar 

  59. Verbiest H (1954) A radicular syndrome from developmental narrowing of the lumbae vertebral canal. J Bone Joint Surg 36B:230–237

    Google Scholar 

  60. Verbiest H (1973) Neurogenic intermittent claudication in cases with absolute and relative stenosis of the lumbar vertebral canal (ASLC and RSLC), in cases with narrow lumbar intervertebral foramina, and in cases with both entities. Clin Neurosurg 20:204–214

    CAS  PubMed  Google Scholar 

  61. Verbiest H (1976) Fallacies of the present definition, nomenclature, and classification of the stenoses of the lumbar vertebral canal. Spine 1:217–225

    Google Scholar 

  62. Willen J, Danielson B, Gaulitz A et al. (1997) Dynamic effects on the lumbar spinal canal: axially loaded CT-myelography and MRI in patients with sciatica and/or neurogenic claudication. Spine 22:2968–2976

    PubMed  Google Scholar 

  63. Yerby S, Lindsey D, Swanson K et al. (2002) Influence of an interspinous spacer on the kinematics of the lumbar spine. In: Trans Eurospine. Nantes, France

  64. Yerby S, Lindsey D, Swanson K et al. (2002) Influence of an interspinous spacer on the kinematics of the lumbar spine. In Trans Int Meeting on Advanced Spine Techniques, Montreux

  65. Yoshida M, Shima K, Taniguchi Y et al. (1992) Hypertrophied ligamentum flavum in lumbar spinal canal stenosis. Pathogenesis and morphologic and immunohistochemical observation. Spine 17:1353–1360

    CAS  PubMed  Google Scholar 

  66. Zucherman J, Hsu K, Hartjen C et al. (2002) Multicenter randomized prospective trial for treatment of lumbar neurogenic claudication with an interspinous device: 1-year results. In: Trans Int Soc for the Study of the Lumbar Spine, Cleveland, Ohio

  67. Zucherman J, Hsu K, Hartjen C et al. (2002) Treatment of lumbar spinal stenosis with an interspinous spacer. In: Trans Int Meeting on Advanced Spine Techniques, Montreux

  68. Zucherman J, Hsu K, Hartjen C et al. (2002) Treatment of lumbar spinal stenosis with an interspinous spacer. In: Trans North American Spine Society, Montreal

  69. Zucherman J, Hsu K, Hartjen C et al. (2002) Treatment of lumbar spinal stenosis with an interspinous spacer. In: Trans Eurospine. Nantes, France

Download references

Acknowledgement

The authors thank the staff at each of the participating medical centers and St. Francis Medical Technologies for their support.

Author information

Authors and Affiliations

  1. St. Mary’s Spine Center, Suite 450, One Shrader Street, San Francisco, CA , 94117, USA

    J. F. Zucherman & K. Y. Hsu

  2. Greater Baltimore Medical Center, Baltimore, Maryland

    C. A. Hartjen

  3. Maine Medical Center, Portland, Maine

    T. F. Mehalic

  4. Somerset Medical Center, Somerset, New Jersey

    D. A. Implicito, P. P. Vessa & J. W. Dwyer

  5. Tacoma General Hospital, Tacoma, Washington

    M. J. Martin

  6. East Cooper Medical Center, Mount Pleasant, South Carolina

    D. R. Johnson II

  7. East Virginia Medical School, Norfolk, Virginia

    G. A. Skidmore

  8. Brigham and Women’s Hospital, Boston, Massachusetts

    S. Puccio & R. M. Ozuna

  9. North Florida Regional Medical Center, Gainesville, Florida

    J. C. Cauthen

Authors
  1. J. F. Zucherman
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. K. Y. Hsu
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. C. A. Hartjen
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. T. F. Mehalic
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. D. A. Implicito
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. M. J. Martin
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. D. R. Johnson II
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. G. A. Skidmore
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. P. P. Vessa
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. J. W. Dwyer
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. S. Puccio
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. J. C. Cauthen
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. R. M. Ozuna
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to J. F. Zucherman.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Zucherman, J.F., Hsu, K.Y., Hartjen, C.A. et 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 13, 22–31 (2004). https://doi.org/10.1007/s00586-003-0581-4

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00586-003-0581-4

Keywords

search

Navigation