STUDY DESIGN: Prospective study analyzing midterm clinical results of total lumbar disc replacement (TDR) with ProDisc II performed at different lumbar motion segments. OBJECTIVES: To assess the influence of the disc level and number of discs replaced following TDR on postoperative outcome. SUMMARY OF BACKGROUND DATA: Multisegmental disc replacement procedures belong to the so-called "off-label" indications for disc replacement, which still lack evidence of noninferiority when compared with fusion procedures. Results from uncontrolled clinical trials regarding monosegmental versus multisegmental disc replacements are contradictory. METHODS: The influence of the level and the number of lumbar discs replaced on postoperative outcome was analyzed prospectively according to Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and numerous clinical parameters. Post-TDR pain patterns were analyzed with fluoroscopically guided spine infiltrations. RESULTS: A total of 99 patients from 3 treatment groups with a mean follow-up of 25.8 months (range, 12.1-57.5 months) achieved significant improvement of preoperative VAS and ODI levels (P < 0.05). Best results and highest patient satisfaction rates (90.9%) were achieved in patients with monosegmental TDR at L4-L5 (n = 22). Results deteriorated when monosegmental TDR was performed at the lumbosacral junction (n = 57) with a tendency toward statistical significance at 24-month follow-up (P = 0.07). Postoperative outcome was significantly inferior following bisegmental disc replacements at L4-L5 + L5-S1 (n = 20) with a considerably higher complication rate when compared with monosegmental TDR procedures. Fluoroscopically guided spine infiltrations confirmed that the incidence of postoperative pain from posterior joint structures was 9.1% (n = 2) for L4-L5 TDR, 28.1% (n = 16) following L5-S1, and 60.0% (n = 12) for bisegmental-TDR at L4-L5 + L5-S1, respectively. CONCLUSION: The level and the number of lumbar disc replacements influence postoperative outcome significantly. Satisfactory outcome was achieved for monosegmental L4-L5 and L5-S1 disc replacement procedures with best results achieved following TDR at L4-L5. For bisegmental TDR, complication rates are significantly higher and inferior postoperative results are to be expected. The incidence of postoperative pain originating from facet and/or iliosacral joints is currently underestimated and will require further investigation.
STUDY DESIGN: Prospective study analyzing midterm clinical results of total lumbar disc replacement (TDR) with ProDisc II performed at different lumbar motion segments. OBJECTIVES: To assess the influence of the disc level and number of discs replaced following TDR on postoperative outcome. SUMMARY OF BACKGROUND DATA: Multisegmental disc replacement procedures belong to the so-called "off-label" indications for disc replacement, which still lack evidence of noninferiority when compared with fusion procedures. Results from uncontrolled clinical trials regarding monosegmental versus multisegmental disc replacements are contradictory. METHODS: The influence of the level and the number of lumbar discs replaced on postoperative outcome was analyzed prospectively according to Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and numerous clinical parameters. Post-TDR pain patterns were analyzed with fluoroscopically guided spine infiltrations. RESULTS: A total of 99 patients from 3 treatment groups with a mean follow-up of 25.8 months (range, 12.1-57.5 months) achieved significant improvement of preoperative VAS and ODI levels (P < 0.05). Best results and highest patient satisfaction rates (90.9%) were achieved in patients with monosegmental TDR at L4-L5 (n = 22). Results deteriorated when monosegmental TDR was performed at the lumbosacral junction (n = 57) with a tendency toward statistical significance at 24-month follow-up (P = 0.07). Postoperative outcome was significantly inferior following bisegmental disc replacements at L4-L5 + L5-S1 (n = 20) with a considerably higher complication rate when compared with monosegmental TDR procedures. Fluoroscopically guided spine infiltrations confirmed that the incidence of postoperative pain from posterior joint structures was 9.1% (n = 2) for L4-L5 TDR, 28.1% (n = 16) following L5-S1, and 60.0% (n = 12) for bisegmental-TDR at L4-L5 + L5-S1, respectively. CONCLUSION: The level and the number of lumbar disc replacements influence postoperative outcome significantly. Satisfactory outcome was achieved for monosegmental L4-L5 and L5-S1 disc replacement procedures with best results achieved following TDR at L4-L5. For bisegmental TDR, complication rates are significantly higher and inferior postoperative results are to be expected. The incidence of postoperative pain originating from facet and/or iliosacral joints is currently underestimated and will require further investigation.
Authors: Christian Hellum; Lars Gunnar Johnsen; Øyvind Gjertsen; Linda Berg; Gesche Neckelmann; Oliver Grundnes; Ivar Rossvoll; Jan Sture Skouen; Jens Ivar Brox; Kjersti Storheim Journal: Eur Spine J Date: 2012-01-13 Impact factor: 3.134
Authors: Christoph J Siepe; Franziska Heider; Elisabeth Haas; Wolfgang Hitzl; Ulrike Szeimies; Axel Stäbler; Christoph Weiler; Andreas G Nerlich; Michael H Mayer Journal: Eur Spine J Date: 2012-05-29 Impact factor: 3.134
Authors: Christoph J Siepe; Karsten Wiechert; Mohamed F Khattab; Andreas Korge; H Michael Mayer Journal: Eur Spine J Date: 2007-01-05 Impact factor: 3.134
Authors: Michael Katsimihas; Christopher S Bailey; Khalil Issa; Jennifer Fleming; Patricia Rosas-Arellano; Stewart I Bailey; Kevin R Gurr Journal: Can J Surg Date: 2010-12 Impact factor: 2.089
Authors: Stephane Aunoble; Robert Meyrat; Yasser Al Sawad; C Tournier; Philip Leijssen; Jean-Charles Le Huec Journal: Eur Spine J Date: 2009-11-04 Impact factor: 3.134