Variation in Reported Safety of Lumbar Interbody Fusion
- 1 February 2007
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Spine
- Vol. 32 (4), 471-480
- https://doi.org/10.1097/01.brs.0000255809.95593.3b
Abstract
Study Design. Systematic review. Objective. To quantify variability in undesirable outcomes among studies of lumbar interbody fusion using stand-alone cage devices, and to determine whether author conflicts of interest contribute to variability. Summary of Background Data. Promising early studies of lumbar fusion with stand-alone cage devices led to rapid uptake of the technique, but some surgeons later expressed reservations regarding efficacy and safety. Methods. We systematically identified studies of lumbar interbody fusion with stand-alone cage devices that reported at least one undesirable outcome among 10 or more adult subjects. We performed meta-analyses of rates of 7 prespecified outcomes (nonunion, reoperation, major vessel injury, retrograde ejaculation, neurologic injury, dural injury, and infection). Heterogeneity in outcome rates was quantified as I-2 (the proportion of variance due to differences among studies rather than random variation). Random-effects meta-regression identified sources of observed heterogeneity, including potential conflicts of interest. Results. We identified 30 eligible studies, including a total of 3228 subjects. A potential conflict of interest was identified in 18 (60%). We observed marked heterogeneity in rates of nonunion, reoperation, and neurologic injury (I-2 > 85%; P < 0.001), and substantial heterogeneity in rates of dural injury (I-2 = 63%; P < 0.01) and major vessel injury (I-2 = 38%; P = 0.09). Among 24 studies reporting fusion status after 6 months of follow-up, nonunion rates ranged from 2.3% to 83.3% (median, 8.3%) and exceeded 45% in 4 studies. Potential author conflict of interest was associated with significantly lower rates of nonunion (P = 0.001). Heterogeneity in rates of other undesirable outcomes was not significantly associated with author conflicts of interest or other study characteristics. Conclusion. We quantified substantial unexplained variation in reported complication rates of undesirable outcomes of lumbar interbody fusion with stand-alone cage devices. Authors with potential conflicts of interest, however, reported significantly lower rates of nonunion.Keywords
This publication has 45 references indexed in Scilit:
- Association Between Funding Source and Study Outcome in Orthopaedic ResearchPublished by Ovid Technologies (Wolters Kluwer Health) ,2003
- Measuring inconsistency in meta-analysesBMJ, 2003
- Posterior lumbar interbody fusion using titanium cylindrical threaded cages: is optimal interbody fusion possible without other instrumentation?Journal of Orthopaedic Science, 2003
- Quantifying heterogeneity in a meta‐analysisStatistics in Medicine, 2002
- Laparoscopic spinal fusion of L4-L5 and L5-S1Surgical Endoscopy, 2001
- What contributions do languages other than English make on the results of meta-analyses?Journal of Clinical Epidemiology, 2000
- Anterior lumbar interbody fusion with threaded fusion cages and autologous bone graftsEuropean Spine Journal, 2000
- The Use of rhBMP-2 in Interbody Fusion CagesSpine, 2000
- A Prospective Study of Laparoscopic Spinal FusionAnnals of Surgery, 1996
- Dissemination of effectiveness and outcomes researchHealth Policy, 1995