Study Design. Literature research.
Objective. To analyze the available evidence about a variety of factors that might affect outcome of lumbar artificial disc replacement.
Summary of Background Data. Evaluating the scientific merit of new technology is important for a clinician considering incorporating these techniques. An evidence-based medicine approach can aid in this decision-making process.
Methods. Eleven questions were asked about patient selection issues, surgical accuracy of placement, and evidence that motion preservation alters the natural history of degeneration. Studies where answers were found were ranked according to their level of evidence.
Results. The majority of studies found were level IV, with only limited numbers of higher level studies. Only lower level studies with conflicting results assess the effect on outcomes of single versus multilevel surgery, L4-L5 versus L5-S1 implantations, patient's age, and history of previous surgery. One lower level study suggests that mild-to-moderate facet degeneration does not influence outcomes. The extent of preoperative facet degeneration that can be accepted remains unclear, as level IV studies report degradation of facet degeneration after implantation. Higher level studies support the importance of surgical precision on clinical outcome and lower level studies give mixed results on the same issue. A level III prognostic study suggests that higher range of motion of the implanted segment may be associated with better outcomes, whereas 2 level IV therapeutic studies provide conflicting results. The incidence of adjacent level degeneration in lower level studies ranges between 17% and 28.6%, and can require additional surgery in 2% to 3% of patients. Two level IV studies suggest that preservation of motion may have a prophylactic effect on adjacent discs.
Conclusion. Existing evidence does not provide definite conclusions in the majority of the questions regarding indications and factors that may affect outcomes. Where feasible, conclusions are mainly drawn from lower level, least reliable evidence. Highest quality data are short-term whereas longer-term data are of lower quality and in many instances conflicting. More high level studies with long-term follow-up are necessary to shed light to important clinical issues.