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Twenty-four month follow-up for reporting results of spinal implant studies: Is this guideline supported by the literature?

Donna D. Ohnmeiss, Dr.Med, Richard D. Guyer, MD

Texas Back Institute Research Foundation, Plano, Texas

Abstract 

Background

Traditionally, spine societies and journals have set guidelines requiring a minimum 24-month follow-up for reporting results of surgical implant studies. However, the basis for this particular time period is not clear. The purpose of this study was to analyze prospective spinal implant studies reporting data at multiple specific follow-up periods to determine if there were significant changes in the clinical outcome throughout the 24-month follow-up period.

Methods

A comprehensive literature search was conducted using PubMed as well as searching the FDA web page. Studies were evaluated to identify those meeting the inclusion criteria: involved at least 100 patients receiving a spinal implant with data reported at multiple pre-defined time periods post-operatively for at least 24-months. Data recorded from each study included, number of patients, diagnoses, implant used, outcome measures used, and the results reported. The primary outcome data were analyzed in the current study to determine the amount of change in scores, with particular focus on the six and 24-month follow-up periods.

Results

Only 7 studies met the inclusion criteria. All seven studies were FDA-regulated trials published since 1997. Six addressed the treatment of symptomatic disc degeneration and 1 involved patients with neurogenic claudication due to stenosis. The outcome measures in the studies varied but pain and function were frequently assessed. In none of the studies was there a significant deterioration in results between the 6 and 24-month follow-up periods. In fact, the only changes during the follow-up periods were slight, not statistically significant, improvements, with the exception of 1 scale in 1 study where a slight, not statistically significant, decrease in the extent of improvement on a physical function assessment was noted between 6 and 24 months. These results suggest a great deal of stability in the mean scores for various outcome measures between the 6 and 24 months in patients receiving spinal implants.

Conclusions

Although long-term follow-up is certainly desirable for any clinical outcome study, there appears to be no significant change in outcome measures between the 6-month and 24-month follow-ups. These results support that earlier dissemination of results may be appropriate without producing overly-optimistic reports.

keywords: 
clinical outcome, Spinal implants, Prospective studies
Volume 3 Issue 3
doi: 
10.1016/j.esas.2009.09.003