Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial |
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Authors: | Caroline Sköld Hans Tropp Svante Berg |
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Institution: | .Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden ;.Department of Orthopaedics, Uppsala University Hospital, SE-751 85 Uppsala, Sweden ;.Department of Spinal Surgery, Linköping University Hospital, SE-581 85 Linköping, Sweden ;.Department of Neuroscience, Karolinska Institutet, Solna, Sweden ;.Stockholm Spine Centre, Löwenströmska Hospital, SE-194 89 Upplands Väsby, Sweden |
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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. |
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Keywords: | Degenerative disc disease Prospective randomized controlled trial Total disc replacement Spinal fusion Global assessment of back pain |
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