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Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial

Michael J. Musacchio, MD,1 Carl Lauryssen, MD,2 Reginald J. Davis, MD,3 Hyun W. Bae, MD,4 John H. Peloza, MD,5 Richard D. Guyer, MD,6 Jack E. Zigler, MD,6 Donna D. Ohnmeiss, DrMed,7 Scott Leary, MD8

1Department of Neurosurgery, NorthShore University HealthSystem, Evanston, IL, 2 NeuroTexas, Austin, TX, 3Laser Spine Institute, Philadelphia, PA, 4The Spine Institute, Santa Monica, CA, 5Texas Back Institute, Frisco, TX, 6Texas Back Institute, Plano, TX, 7Texas Back Institute Research Foundation, Plano, TX, 8Senta Clinic, San Diego, CA

Abstract

Introduction

If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device.

Methods

This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex® Interlaminar Stabilization® device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) >15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. 

Results

At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p>0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p >0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating >15 point improvement (p>0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. 

Conclusion

Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels.

Level of Evidence and Ethical Statements

This is a Level I study. Institutional approval was received at each of the sites participating in the trial. Each patient gave informed consent to participate in the trial.

keywords: 
interlaminar device, spinal stenosis, lumbar spine, decompression, instrumented fusion, clinical outcome, randomized study
Volume 10 Article 6
doi: 
10.14444/3006