13 - Impact of Facet Replacement vs TLIF in a Prospective Randomized FDA Study on ODI and Post-Operative Opioid Utilization among Subjects at 24 Months

Friday, June 2, 2023

11:42 AM – 11:46 AM

Location: Salons 10-12

Presenting Author (Person doing the Podium Present(s)

HD

Harel Deutsch, MD

Associate Professor of Neurosurgery
Rush
Chicago, Illinois, United States

Co-Author(s)

DC

Domagoj Coric, MD

Neurosurgeon
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
MS

Michael Steinmetz, MD

United States
AN

Ahmad Nassr, MD

Consultant
Mayo Clinic
Rochester, MN, United States
WW

William Welch

Pennsylvania, United States
JZ

James Zucherman

United States
RK

Roland S. Kent, MD

Orthopedic Spine surgeon
Axis Spine Center
Hayden Lake, Idaho, United States
AK

Andy J. Kranenburg, MD

Orthopedic Surgeon
Southern Oregon Orthopedics
Medford, OR, United States
JC

John Chi

United States
MG

Michael Groff, MD

United States

Submitter(s)

HD

Harel Deutsch, MD

Associate Professor of Neurosurgery
Rush
Chicago, Illinois, United States

Introduction
Treatment of pain associated with lumbar spondylolisthesis and stenosis can be treated with narcotics. Long term narcotic use, however, is associated with potentially life-threatening side effects and has been shown to negatively affect clinical outcomes following lumbar spine surgery. Lumbar facet arthroplasty represents a possible alternative to current surgical treatment options for patients suffering from lumbar spondylolisthesis and stenosis. The effect of facet replacement arthroplasty versus lumbar fusion on opioid utilization is a worthwhile outcome measure.

Objective
This study examines the association of post-operative opioid use and clinical outcomes among patients undergoing facet arthroplasty and fusion surgery.

Methods
This interim analysis from a randomized, prospective study examined 299 subjects with Grade 1 spondylolisthesis with at least moderate stenosis that underwent decompressive laminectomy via a mid-line incision at one lumbar level followed by randomization (2:1) to either facet arthroplasty with the TOPS System or to posterior lumbar interbody fusion. Primary endpoints were improvement in Oswestry Disability Index (ODI) and post-operative opioid use through 24 months of follow-up.

Results
There were no significant differences (p>0.40) in baseline demographics or operative characteristics. Post-operatively the TOPS group reported a greater percent improvement in ODI than TLIF with mean group difference of -13.2% at 3 months (p=0.001), -7.1% at 6 months (p=0.07), -10.6% at 12 months (p=0.01), and -17.8% at 24 months (p=0.002). Opioid use over the same timepoints was similar for both groups with no statistical difference (p>0.15). The percentage of subjects reporting opioid use among the TOPS group at 3, 6, 12, and 24 months was 13.9%, 11.2%, 10.4%, and 11.0% compared to TLIF at 21.2%, 15.0%, 12.7%, and 18.8%.

Conclusion
Meaningful reductions in both opioid use and ODI through 12 months of follow-up are seen in both study groups. However at 24 months the fusion group trended towards a slight increase in opioid use and this coincides with slightly worsening ODI scores. ODI improvements were statistically better in the facet arthroplasty group. For subjects that undergo facet arthroplasty, the use of narcotics post-operatively was lower than among fusion patients at all observed timepoints although narcotic use was not statistically different between the two groups.