Skip to main content

Advertisement

Log in

Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial

  • Original Article
  • Published:
European Spine Journal Aims and scope Submit manuscript

Abstract

Purpose

To evaluate long-term clinical results of lumbar total disc replacement (TDR) compared with posterior lumbar fusion.

Methods

This prospective randomized controlled trial comprised 152 patients; 80 were randomized to TDR and 72 to fusion. All patients had chronic low back pain (CLBP) and had not responded to nonsurgical treatment. Primary outcome measure was global assessment of back pain (GA), secondary outcome measures were back and leg pain, Oswestry Disability Index (ODI), EQ5D, and SF-36. All measures were collected from SweSpine (Swedish national register for spinal surgery) at 1, 2, and 5 years. Follow-up rate at 5 years was 99.3 %.

Results

Both groups showed clinical improvement at 5-year follow-up. For GA, 38 % (30/80) in the TDR group were totally pain free vs. 15 % (11/71) in the fusion group (p < 0.003). Back pain and improvement of back pain were better in the TDR group: VAS back pain at 5 years 23 ± 29 vs. 31 ± 27, p = 0.009, and VAS improvement of back pain at 5 years 40 ± 32 vs. 28 ± 32, p = 0.022. ODI and improvement in ODI were also better in the TDR group: ODI at 5 years 17 ± 19 vs. 23 + 17, p = 0.02 and ODI improvement at 5 years 25 ± 18 vs. 18 ± 19 (p = 0.02). There was no difference in complications and reoperations between the two groups.

Conclusions

Global assessment of low back pain differed between the two surgical groups at all follow-up occasions. Significant differences between groups concerning back pain, pain improvement, and ODI were present at 1 year and disappeared at 2 years, but reappeared at the 5-year follow-up.

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

Access this article

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

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Chou R, Baisden J, Carragee EJ, Resnick DK, Shaffer WO, Loeser JD (2009) Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine 34:1094–1109

    Article  PubMed  Google Scholar 

  2. Mirza SK, Deyo RA (2007) Systematic review of randomized trials comparing lumbar fusion surgery to nonoperative care for treatment of chronic back pain. Spine 32:816–823

    Article  PubMed  Google Scholar 

  3. Fritzell P, Hägg O, Wessberg P, Nordwall A (2001) 2001 volvo award winner in clinical studies: lumbar fusion versus nonsurgical treatment for chronic low back pain. Spine 26:2521–2532

    Article  PubMed  CAS  Google Scholar 

  4. Brox JI, Sørensen R, Friis A, Nygaard Ø, Indahl A, Keller A, Ingebrigtsen T et al (2003) Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine 28:1913–1921

    Article  PubMed  Google Scholar 

  5. Fairbank J, Frost H, Wilson-Macdonald J, Yu L, Barker K, Collins R (2005) Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ 330:1–7

    Article  Google Scholar 

  6. Brox JI, Nygaard ØP, Holm I, Keller A, Ingebrigtsen T, Reikerås O (2010) Four-year follow-up of surgical versus non-surgical therapy for chronic low back pain. Ann Rheum Dis 69:1643–1648

    Article  PubMed  Google Scholar 

  7. Froholdt A, Reikeraas O, Holm I, Keller A, Brox JI (2012) No difference in 9-year outcome in CLBP patients randomized to lumbar fusion versus cognitive intervention and exercises. Eur Spine J 21:2531–2538

    Article  PubMed  Google Scholar 

  8. Ghiselli G, Wang JC, Bhatia NN, Hsu WK, Dawson EG (2004) Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am 86-A(7):1497–1503

    PubMed  Google Scholar 

  9. Gillet P (2003) The fate of the adjacent motion segments after lumbar fusion. J Spinal Disord Tech 16:338–345

    Article  PubMed  Google Scholar 

  10. Kumar MN, Jacquot F, Hall H (2001) Long-term follow-up of functional outcomes and radiographic changes at adjacent levels following lumbar spine fusion for degenerative disc disease. Eur Spine J 10:309–313

    Article  PubMed  CAS  Google Scholar 

  11. Park P, Garton HJ, Gala VC, Hoff JT, McGillicuddy JE (2004) Adjacent segment disease after lumbar or lumbosacral fusion: review of the literature. Spine 29:1938–1944

    Article  PubMed  Google Scholar 

  12. Blumenthal S, McAfee PC, Guyer RD, Hochschuler SH, Geisler FH, Holt RT, Garcia R et al (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine 30:1565–1575 (discussion E387–391)

    Article  PubMed  Google Scholar 

  13. Zigler J, Delamarter R, Spivak JM, Linovitz RJ, Danielson GO, Haider TT, Cammisa F et al (2007) Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine 32:1155–1162 (discussion 1163)

    Article  PubMed  Google Scholar 

  14. Guyer RD, McAfee PC, Banco RJ, Bitan FD, Cappuccino A, Geisler FH, Hochschuler SH et al (2009) Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up. Spine J 9:374–386

    Article  PubMed  Google Scholar 

  15. Berg S, Tullberg T, Branth B, Olerud C, Tropp H (2009) Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up. Eur Spine J 18:1512–1519

    Article  PubMed  Google Scholar 

  16. Hellum C, Johnsen LG, Storheim K, Nygaard OP, Brox JI, Rossvoll I, Ro M et al (2011) Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study. BMJ 342:d2786

    Article  PubMed  Google Scholar 

  17. Zigler JE, Delamarter RB (2012) Five-year results of the prospective, randomized, multicenter, food and drug administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc. J Neurosurg Spine 17:493–501

    Article  PubMed  Google Scholar 

  18. Chao S, Malloy JP, Bono CM (2011) Complications specific to motion-sparing devices in the lumbar spine. Semin Spine Surg 23:123–134

    Article  Google Scholar 

  19. Jacobs W, Na VDG, Tuschel AMDK, Peul W, Aj V, Fc O (2012) Total disc replacement for chronic discogenic low back pain: a cochrane review. Spine 38:24–36

    Article  Google Scholar 

  20. Fairbank JC, Pynsent PB (2000) The Oswestry Disability Index. Spine 25:2940–2952 (discussion 2952)

    Article  PubMed  CAS  Google Scholar 

  21. The EuroQol Group (1990) EuroQol–a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 16:199–208

    Article  Google Scholar 

  22. Ware JE, Sherbourne CD (1992) The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 30:473–483

    Article  PubMed  Google Scholar 

  23. Berg S, Tropp H, Leivseth G (2011) Disc height and motion patterns in the lumbar spine in patients operated with total disc replacement or fusion for discogenic back pain. Results from a randomized controlled trial. Spine J 11:991–998

    Article  PubMed  Google Scholar 

  24. Fritzell P, Hägg O, Wessberg P, Nordwall A (2002) Chronic low back pain and fusion: a comparison of three surgical techniques: a prospective multicenter randomized study from the Swedish lumbar spine study group. Spine 27:1131–1141

    Article  PubMed  Google Scholar 

  25. Scheer SJ, Watanabe TK, Radack KL (1997) Randomized controlled trials in industrial low back pain. Part 3. Subacute/chronic pain interventions. Arch Phys Med Rehabil 78:414–423

    Article  PubMed  CAS  Google Scholar 

  26. Taylor ME (1989) Return to work following back surgery: a review. Am J Ind Med 16:79–88

    Article  PubMed  CAS  Google Scholar 

  27. Berg S, Tropp H (2010) Results from a randomized controlled study between total disc replacement and fusion compared with results from a spine register. SAS J 4:68–74

    Article  Google Scholar 

Download references

Acknowledgments

The authors declare that they did not receive any compensation for this work.

Conflict of interest

None.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Caroline Sköld.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Sköld, C., Tropp, H. & Berg, S. Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial. Eur Spine J 22, 2288–2295 (2013). https://doi.org/10.1007/s00586-013-2926-y

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00586-013-2926-y

Keywords

Navigation