Caroline Sköld1, Hans Tropp, Svante Berg. 1. Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden, skold.caroline@gmail.com.
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.
RCT Entities:
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.
Authors: Wilco C H Jacobs; Niels A van der Gaag; Moyo C Kruyt; Alexander Tuschel; Marinus de Kleuver; Wilco C Peul; Abraham J Verbout; F Cumhur Oner Journal: Spine (Phila Pa 1976) Date: 2013-01-01 Impact factor: 3.468
Authors: Roger Chou; Jamie Baisden; Eugene J Carragee; Daniel K Resnick; William O Shaffer; John D Loeser Journal: Spine (Phila Pa 1976) Date: 2009-05-01 Impact factor: 3.468
Authors: Jens Ivar Brox; Øystein P Nygaard; Inger Holm; Anne Keller; Tor Ingebrigtsen; Olav Reikerås Journal: Ann Rheum Dis Date: 2009-07-26 Impact factor: 19.103
Authors: Emin Aghayev; Christian Etter; Christian Bärlocher; Friedrich Sgier; Philippe Otten; Paul Heini; Oliver Hausmann; Gianluca Maestretti; Martin Baur; François Porchet; Thomas M Markwalder; Stefan Schären; Michal Neukamp; Christoph Röder Journal: Eur Spine J Date: 2014-06-20 Impact factor: 3.134
Authors: Tobias A Mattei; Azeem A Rehman; Alisson R Teles; Jean C Aldag; Dzung H Dinh; Todd D McCall Journal: Neurosurg Rev Date: 2016-06-11 Impact factor: 3.042