Evidence-Based Recommendations for Spine Surgery

Alexander R. Vaccaro, MD, PhD, MBA; Charles G. Fisher, MD; Srinivas K. Prasad, MD; Alpesh A. Patel, MD, FACS; John Chi, MD, MPH; Kishore Mulpuri, MBBS, MHSc; Kenneth C. Thomas, MD, MHSc; Peter G. Whang, MD, FACS

Disclosures

Spine. 2020;45(21):E1441-E1448. 

In This Article

Methodological Review

The inclusion and exclusion criteria are applicable to the research objectives of the study and should allow for the selection of a representative subject population with symptomatic neurogenic claudication and/or radiculopathy secondary to degenerative or lytic spondylolisthesis deformities. Similarly, the selected outcome measures are generally appropriate and should provide sufficient data to distinguish between these two distinct surgical procedures. Randomization will be performed using a computer-generated program with predefined block allocation to ensure that there are balanced group sizes at the end of enrollment. Sample size calculations were completed based upon a 20 mm difference in VAS scores for low back pain with a standard deviation of 40 mm, alpha of 0.05, and beta of 0.10; assuming a 8% loss to follow-up, it was estimated that a total of 184 individuals will need to be enrolled into the trial. All statistical analyses will be performed according to the intention-to-treat principle.

Although the authors suggest that any perceived differences in terms of recovery and/or pain may occur within the first 6 weeks after surgery with similar outcomes thereafter, the follow-up time period will be extended to 2 years which certainly seems prudent. This investigation also is subject to routine safety monitoring with standard adverse event monitoring precautions. Of note, because the incisions for the two different surgeries are different, blinding of the patients and assessors will not be feasible.

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