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

Study Summary

The minimally invasive surgery versus open surgery study is a prospective, multicenter, randomized controlled trial which is designed to characterize the clinical, functional, and radiographic outcomes associated with these two operative approaches for decompressing and stabilizing sagittal plane deformities of the lumbar spine. Subjects with symptomatic degenerative or spondylolytic spondylolisthesis will be randomly assigned to undergo either a standard open decompression and instrumented arthrodesis with placement of polyetheretherketone posterior interbody spacers bilaterally through a single incision with a subperiosteal exposure and retraction of the paravertebral musculature or a less invasive "mini-open" midline decompression/posterior interbody fusion with percutaneous pedicle screws inserted through small paramedian incisions (open and MISS cohorts, respectively). Relevant inclusion criteria include age between 18 and 75 years; a minimum of 3 months of symptoms of neurogenic claudication and/or radiculopathy with or without back pain which did not improve following a reasonable regimen of nonoperative care, and radiographic evidence of a degenerative or spondylolytic spondylolisthesis (Meyerding grades I or II).

The primary outcome measure is self-reported back pain quantified using the VAS; several other secondary metrics will also be considered including Oswestry Disability Index (ODI), Likert scale for patients' perceived recovery, neurologic function, VAS for leg pain, EurQol instrument for quality of life, resumption of work, reoperation rate, surgical parameters (i.e., blood loss, operative time, and length of hospital stay), complications, fusion status based upon dynamic lateral x-rays, and correction of spondylolisthesis. All subjects will be evaluated preoperatively as well as at the following postoperative time points: 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. Regardless, the focus of this investigation will be on identifying any short-term improvements in recovery and pain between these two groups (i.e., 2 and 6 wk after surgery) since these are likely to be the most apparent benefits associated with a less invasive approach. The authors hypothesize that the subjects in the MISS cohort will exhibit a faster speed of recovery and decreased back pain at 2 and 6 weeks postoperatively with equivalent outcomes at 1 year compared with those randomized to treatment with open fusion surgery.

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