Advertisement

European Spine Journal

, Volume 26, Issue 2, pp 404–413 | Cite as

The effectiveness of decompression alone compared with additional fusion for lumbar spinal stenosis with degenerative spondylolisthesis: a pragmatic comparative non-inferiority observational study from the Norwegian Registry for Spine Surgery

  • Ivar M. AustevollEmail author
  • Rolf Gjestad
  • Jens Ivar Brox
  • Tore K. Solberg
  • Kjersti Storheim
  • Frode Rekeland
  • Erland Hermansen
  • Kari Indrekvam
  • Christian Hellum
Original Article

Abstract

Purpose

To evaluate the effect of adding fusion to decompression in patients operated for lumbar spinal stenosis with a concomitant lumbar degenerative spondylolisthesis.

Methods

After propensity score matching, 260 patients operated with decompression and fusion and 260 patients operated with decompression alone were compared. Primary outcome measures were leg and back pain [Numeric Rating Scale (NRS), 0–10] and Oswestry Disability Index (ODI, 0–100) at 12 months.

Results

At 12-month follow-up, the fusion group rated their pain significantly lower than the decompression alone group [leg pain 3.0 and 3.6, respectively, mean difference −0.6, 95 % confidence interval (CI) −1.2 to −0.05, p = 0.03 and back pain 3.3 and 3.9, respectively, mean difference −0.6, 95 % CI −1.1 to −0.1, p = 0.02]. ODI was not significantly different between the groups (21.0 versus 23.3, mean difference −2.3, 95 % CI −5.8 to 1.1, p = 0.18). Seventy-four percent of the fusion group and 63 % of the decompression alone group achieved a clinically important improvement in back pain (difference in proportion of responders = 11 %, 95 % CI 2–20 %, p = 0.01), corresponding to a number needed to treat of 9 patients (95 % CI 5–50). There was no significant difference in responder rate for leg pain (74 and 67 %, respectively, difference 7 %, 95 % CI −1 to 16 %, p = 0.09) or for ODI (67 and 59 %, respectively, difference 8 %, 95 % CI 0–18 %, p = 0.06). The duration of surgery and hospital stay was longer for the fusion group (mean difference 68 min, 95 % CI 58–78, p < 0.01 and mean difference 4.2 days, 95 % CI 3.5–4.8, p < 0.01).

Conclusion

In the present non-inferiority study, we cannot conclude that decompression alone is as good as decompression with additional fusion. However, the small differences in the groups’ effect sizes suggest that a considerable number of patients can be treated with decompression alone. A challenge in future studies will be to find the best treatment option for each patient.

Keywords

Lumbar spinal stenosis Degenerative spondylolisthesis Treatment Fusion 

Notes

Compliance with ethical standards

Funding

Helse Bergen HF, Haukeland University Hospital, Bergen, Norway.

Conflict of interest

The authors declare that they have no conflict of interest.

References

  1. 1.
    Watters WC 3rd, Bono CM, Gilbert TJ, Kreiner DS, Mazanec DJ, Shaffer WO, Baisden J, Easa JE, Fernand R, Ghiselli G, Heggeness MH, Mendel RC, O’Neill C, Reitman CA, Resnick DK, Summers JT, Timmons RB, Toton JF, North American Spine S (2009) An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis. Spine J 9:609–614CrossRefPubMedGoogle Scholar
  2. 2.
    Cauchoix J, Benoist M, Chassaing V (1976) Degenerative spondylolisthesis. Clin Orthop 115:122–129Google Scholar
  3. 3.
    Mardjetko SM, Connolly PJ, Shott S (1994) Degenerative lumbar spondylolisthesis. A meta-analysis of literature 1970–1993. Spine 19:2256s–2265sCrossRefPubMedGoogle Scholar
  4. 4.
    Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS (2007) Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. NEJM 356:2257–2270CrossRefPubMedPubMedCentralGoogle Scholar
  5. 5.
    Weinstein JN, Lurie JD, Tosteson TD, Zhao W, Blood EA, Tosteson AN, Birkmeyer N, Herkowitz H, Longley M, Lenke L, Emery S, Hu SS (2009) Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. Four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. J Bone Jt Surg (Am) 91:1295–1304CrossRefGoogle Scholar
  6. 6.
    Mannion AF, Pittet V, Steiger F, Vader JP, Becker HJ, Porchet F (2014) Development of appropriateness criteria for the surgical treatment of symptomatic lumbar degenerative spondylolisthesis (LDS). Eur Spine J 23:1903–1917CrossRefPubMedGoogle Scholar
  7. 7.
    Martin CR, Gruszczynski AT, Braunsfurth HA, Fallatah SM, O’Neil J, Wai EK (2007) The surgical management of degenerative lumbar spondylolisthesis: a systematic review. Spine 32:1791–1798CrossRefPubMedGoogle Scholar
  8. 8.
    Resnick DK, Watters WC 3rd, Sharan A, Mummaneni PV, Dailey AT, Wang JC, Choudhri TF, Eck J, Ghogawala Z, Groff MW, Dhall SS, Kaiser MG (2014) Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: lumbar fusion for stenosis with spondylolisthesis. J Neurosurg Spine 21:54–61CrossRefPubMedGoogle Scholar
  9. 9.
    Steiger F, Becker HJ, Standaert CJ, Balague F, Vader JP, Porchet F, Mannion AF (2014) Surgery in lumbar degenerative spondylolisthesis: indications, outcomes and complications. A systematic review. Eur Spine J 23:945–973CrossRefPubMedGoogle Scholar
  10. 10.
    Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG (2010) Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA 303:1259–1265CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Kepler CK, Vaccaro AR, Hilibrand AS, Anderson DG, Rihn JA, Albert TJ, Radcliff KE (2014) National trends in the use of fusion techniques to treat degenerative spondylolisthesis. Spine 39:1584–1589CrossRefPubMedGoogle Scholar
  12. 12.
    Chang HS, Fujisawa N, Tsuchiya T, Oya S, Matsui T (2014) Degenerative spondylolisthesis does not affect the outcome of unilateral laminotomy with bilateral decompression in patients with lumbar stenosis. Spine 39:400–408CrossRefPubMedGoogle Scholar
  13. 13.
    Forsth P, Michaelsson K, Sanden B (2013) Does fusion improve the outcome after decompressive surgery for lumbar spinal stenosis?: a two-year follow-up study involving 5390 patients. Bone Joint J 95-B:960–965CrossRefPubMedGoogle Scholar
  14. 14.
    Sigmundsson FG, Jonsson B, Stromqvist B (2015) Outcome of decompression with and without fusion in spinal stenosis with degenerative spondylolisthesis in relation to preoperative pain pattern: a register study of 1624 patients. Spine J 15:638–646CrossRefPubMedGoogle Scholar
  15. 15.
    von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP (2007) The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 370:1453–1457CrossRefGoogle Scholar
  16. 16.
    Solberg TK, Sorlie A, Sjaavik K, Nygaard OP, Ingebrigtsen T (2011) Would loss to follow-up bias the outcome evaluation of patients operated for degenerative disorders of the lumbar spine? Acta Orthop 82:56–63CrossRefPubMedPubMedCentralGoogle Scholar
  17. 17.
    Grotle M, Brox JI, Vollestad NK (2003) Cross-cultural adaptation of the Norwegian versions of the Roland–Morris Disability Questionnaire and the Oswestry Disability Index. J Rehabil Med 35:241–247CrossRefPubMedGoogle Scholar
  18. 18.
    Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY (2008) Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J 8:968–974CrossRefPubMedGoogle Scholar
  19. 19.
    Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ (2010) Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol 63:760–766CrossRefPubMedGoogle Scholar
  20. 20.
    Austin PC (2011) An introduction to Propensity score methods for reducing the effects of confounding in observational studies. Multivar Behav Res 46:399–424CrossRefGoogle Scholar
  21. 21.
    Schafer JL, Graham JW (2002) Missing data: our view of the state of the art. Psychol Methods 7:147–177CrossRefPubMedGoogle Scholar
  22. 22.
    Bollen KA, Curran PJ (2006) Latent curve models: a structural equation perspective. Wiley, HobokenGoogle Scholar
  23. 23.
    Muthén LK, Muthén BO (2014) Mplus 7.3. In: Muthén, Muthén, 3463 Stoner Avenue, CA 90066, Los AngelesGoogle Scholar
  24. 24.
    Katz N, Paillard FC, Van Inwegen R (2015) A review of the use of the number needed to treat to evaluate the efficacy of analgesics. J Pain 16:116–123CrossRefPubMedGoogle Scholar
  25. 25.
    Blackwelder WC, Chang MA (1984) Sample size graphs for “proving the null hypothesis”. Control Clin Trials 5:97–105CrossRefPubMedGoogle Scholar
  26. 26.
    Herkowitz HN, Kurz LT (1991) Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg (Am) 73:802–808CrossRefGoogle Scholar
  27. 27.
    Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, Guyatt GH, Harbour RT, Haugh MC, Henry D, Hill S, Jaeschke R, Leng G, Liberati A, Magrini N, Mason J, Middleton P, Mrukowicz J, O’Connell D, Oxman AD, Phillips B, Schunemann HJ, Edejer T, Varonen H, Vist GE, Williams JW Jr, Zaza S (2004) Grading quality of evidence and strength of recommendations. BMJ 328:1490CrossRefPubMedGoogle Scholar
  28. 28.
    Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B (2016) A randomized, controlled trial of fusion surgery for lumbar spinal stenosis. NEJM 374:1413–1423CrossRefPubMedGoogle Scholar
  29. 29.
    Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC (2016) Laminectomy plus fusion versus laminectomy alone for lumbar spondylolisthesis. NEJM 374:1424–1434CrossRefPubMedGoogle Scholar
  30. 30.
    Kleinstueck FS, Fekete TF, Mannion AF, Grob D, Porchet F, Mutter U, Jeszenszky D (2012) To fuse or not to fuse in lumbar degenerative spondylolisthesis: do baseline symptoms help provide the answer? Eur Spine J 21:268–275CrossRefPubMedGoogle Scholar
  31. 31.
    Inacio MC, Paxton EW, Dillon MT (2016) Understanding Orthopaedic Registry Studies: a comparison with clinical studies. J Bone Jt Surg Am 98:e3CrossRefGoogle Scholar
  32. 32.
    Ekman P, Moller H, Shalabi A, Yu YX, Hedlund R (2009) A prospective randomised study on the long-term effect of lumbar fusion on adjacent disc degeneration. Eur Spine J 18:1175–1186CrossRefPubMedPubMedCentralGoogle Scholar
  33. 33.
    Mannion AF, Leivseth G, Brox JI, Fritzell P, Hagg O, Fairbank JC (2014) ISSLS Prize winner: long-term follow-up suggests spinal fusion is associated with increased adjacent segment disc degeneration but without influence on clinical outcome: results of a combined follow-up from 4 randomized controlled trials. Spine 39:1373–1383CrossRefPubMedGoogle Scholar
  34. 34.
    Abdu WA, Lurie JD, Spratt KF, Tosteson AN, Zhao W, Tosteson TD, Herkowitz H, Longely M, Boden SD, Emery S, Weinstein JN (2009) Degenerative spondylolisthesis: does fusion method influence outcome? Four-year results of the spine patient outcomes research trial. Spine 34:2351–2360CrossRefPubMedPubMedCentralGoogle Scholar
  35. 35.
    Fox MW, Onofrio BM, Onofrio BM, Hanssen AD (1996) Clinical outcomes and radiological instability following decompressive lumbar laminectomy for degenerative spinal stenosis: a comparison of patients undergoing concomitant arthrodesis versus decompression alone. J Neurosurg 85:793–802CrossRefPubMedGoogle Scholar
  36. 36.
    Kornblum MB, Fischgrund JS, Herkowitz HN, Abraham DA, Berkower DL, Ditkoff JS (2004) Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective long-term study comparing fusion and pseudarthrosis. Spine 29:726–733 (discussion 733–724) CrossRefPubMedGoogle Scholar
  37. 37.
    Tsutsumimoto T, Shimogata M, Yoshimura Y, Misawa H (2008) Union versus nonunion after posterolateral lumbar fusion: a comparison of long-term surgical outcomes in patients with degenerative lumbar spondylolisthesis. Eur Spine J 17:1107–1112CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Ivar M. Austevoll
    • 1
    Email author
  • Rolf Gjestad
    • 4
    • 5
  • Jens Ivar Brox
    • 6
  • Tore K. Solberg
    • 3
    • 7
  • Kjersti Storheim
    • 8
  • Frode Rekeland
    • 1
  • Erland Hermansen
    • 1
    • 2
    • 9
  • Kari Indrekvam
    • 1
    • 2
  • Christian Hellum
    • 3
    • 10
  1. 1.Kysthospitalet in Hagevik, Orthopedic ClinicHaukeland University HospitalBergenNorway
  2. 2.Department of Clinical MedicineUniversity of BergenBergenNorway
  3. 3.Norwegian Registry for Spine Surgery (NORspine)University Hospital of Northern NorwayTromsøNorway
  4. 4.Division of Mental Health CareHaukeland University HospitalBergenNorway
  5. 5.Centre for Research and Education in Forensic PsychiatryHaukeland University HospitalBergenNorway
  6. 6.Department of Physical Medicine and RehabilitationOslo University HospitalOsloNorway
  7. 7.Department of NeurosurgeryUniversity Hospital of Northern NorwayTromsøNorway
  8. 8.Communication and Research Unit for Musculoskeletal Disorders (FORMI)Oslo University Hospital, University of OsloOsloNorway
  9. 9.Department of Orthopedic SurgeryÅlesund Hospital, Møre and Romsdal Hospital TrustÅlesundNorway
  10. 10.Clinic for Surgery and Neurology, Department of OrthopedicsOslo University Hospital, University of OsloOsloNorway

Personalised recommendations