Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial
- 788 Downloads
To evaluate long-term clinical results of lumbar total disc replacement (TDR) compared with posterior lumbar fusion.
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 %.
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.
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.
KeywordsDegenerative disc disease Prospective randomized controlled trial Total disc replacement Spinal fusion Global assessment of back pain
The authors declare that they did not receive any compensation for this work.
Conflict of interest
- 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 330:1–7CrossRefGoogle 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)PubMedCrossRefGoogle 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)PubMedCrossRefGoogle 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 9:374–386PubMedCrossRefGoogle 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 17:493–501PubMedCrossRefGoogle Scholar