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01-02-2004 | Original Article

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

Authors: J. F. Zucherman, K. Y. Hsu, C. A. Hartjen, T. F. Mehalic, D. A. Implicito, M. J. Martin, D. R. Johnson II, G. A. Skidmore, P. P. Vessa, J. W. Dwyer, S. Puccio, J. C. Cauthen, R. M. Ozuna

Published in: European Spine Journal | Issue 1/2004

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.

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

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

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

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

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

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–S197PubMed

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

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

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 14:965–969PubMed

11.

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

12.

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

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 79:700–708PubMed

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 26:876–882CrossRefPubMed

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 384:10–17PubMed

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 77:32–38PubMed

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 10:461–465CrossRefPubMed

19.

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

20.

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

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 11:110–115PubMed

22.

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

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 21:2412–2420CrossRefPubMed

24.

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

25.

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

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 22:2932–2937CrossRefPubMed

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 22:2938–2944CrossRefPubMed

28.

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

29.

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

30.

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

31.

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

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 57:57–63PubMed

35.

Mulholland RC, Sengupta DK (2002) Rationale, principles and experimental evaluation of the concept of soft stabilization. Eur Spine J 11 (Suppl 2):S198–S205PubMed

36.

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

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 12:488–500PubMed

38.

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

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 75:386–392PubMed

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 27:84–91CrossRefPubMed

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 55:581–594CrossRefPubMed

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 7:115–121PubMed

44.

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

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

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–S169PubMed

48.

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

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 25:197–204CrossRefPubMed

50.

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

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–S178PubMed

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 72:99–106PubMed

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 48:1369–1378CrossRefPubMed

54.

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

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 28:26–32CrossRefPubMed

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 17:1–8PubMed

59.

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

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 20:204–214PubMed

61.

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

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 22:2968–2976PubMed

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 17:1353–1360PubMed

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

Title: A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results
Authors: J. F. Zucherman
K. Y. Hsu
C. A. Hartjen
T. F. Mehalic
D. A. Implicito
M. J. Martin
D. R. Johnson II
G. A. Skidmore
P. P. Vessa
J. W. Dwyer
S. Puccio
J. C. Cauthen
R. M. Ozuna
Publication date: 01-02-2004
Publisher: Springer-Verlag
Published in: European Spine Journal / Issue 1/2004
Print ISSN: 0940-6719
Electronic ISSN: 1432-0932
DOI: https://doi.org/10.1007/s00586-003-0581-4

Keynote webinar | Spotlight on medication adherence

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

Abstract

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