Lumbar Spinous Process Fixation and Fusion: A Systematic Review and Critical Analysis of an Emerging Spinal Technology.

STUDY DESIGN: A systematic review.

OBJECTIVE: The available literature on interspinous rigid fixation/fusion devices (IFD) was systematically reviewed to explore the devices' efficacy and complication profile.

SUMMARY OF BACKGROUND DATA: The clinical application of new spinal technologies may proceed without well-established evidence, as is the case with IFDs. IFDs are plate-like devices that are attached to the lateral aspects of 2 adjacent spinous processes to promote rigidity at that segment. Despite almost a decade since the devices' introduction, the literature regarding efficacy and safety is sparse. Complications have been reported but no definitive study is known to the authors.

METHODS: A systematic review of the past 10 years of English literature was conducted according to PRISMA guidelines. The timeframe was chosen based on publication of the first study containing a modern IFD, the SPIRE, in 2006. All PubMed publications containing MeSH headings or with title or abstract containing any combination of the words "interspinous," "spinous process," "fusion," "fixation," "plate," or "plating" were included. Exclusion criteria consisted of dynamic stabilization devices (X-Stop, DIAM, etc.), cervical spine, pediatrics, and animal models. The articles were blinded to author and journal, assigned a level of evidence by Oxford Centre of Evidence-Based Medicine (OCEBM) criteria, and summarized in an evidentiary table.

RESULTS: A total of 293 articles were found in the initial search, of which 15 remained after examination for exclusion criteria. No class I or class II evidence regarding IFDs was found. IFDs have been shown by methodologically flawed and highly biased class III evidence to reduce instability at 1 year, without statistical comparison of complication rates against other treatment modalities.

CONCLUSIONS: Although IFDs are heavily marketed and commonly applied in modern practice, data on safety and efficacy are inadequate. The paucity of evidence warrants reexamination of these devices' value and indications by the spine surgery community.