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Spinal Stenosis in the Absence of Spondylolisthesis: Can Interlaminar Stabilization at Single and Multi-levels Provide Sustainable Relief?

Celeste Abjornson, PhD, Byung-jo Victor Yoon, MS, Tucker Callanan, BS, Daniel Shein, MD, Samuel Grinberg, BA, Frank P. Cammisa, MD

Hospital for Special Surgery, New York, NY, USA

Abstract

Background

In the absence of spondylolisthesis, fusion procedures are generally not recommended. However, decompression alone often does not provide long-term clinical success of intractable leg and back pain. Decompression with interlaminar stabilization (ILS) offers a new clinical continuum of care by providing a non-fusion surgical alternative. The objective of this study is to examine the sustainability of decompression with ILS and to understand the clinical success at either a 1 or 2 levels as a surgical treatment for non-spondylolisthesis patients with spinal stenosis.

Methods

Under FDA-regulated Investigational Device Exemption (IDE) study, a total of 322 patients were enrolled in the prospective, randomized trial. This investigation focuses only on the subset of patients (116 total) from this overall cohort who were treated with decompression + ILS at 1 or 2 levels and who did not present with spondylolisthesis pre-operatively. The patients were assessed before and after surgery up to 60 months.

Results

At 60 months follow-up, there was no statistically significant difference in ODI ≥ 15 point improvement between patient populations (81.6% of 1-level, 90.3% of 2-level). At 60 months 83.1% of 1-level and 86.3% of 2-level patients did not require a secondary surgical procedure. At 60 months, 94.7% of 1-level and 100% of 2-level reported ≥ 20 mm improvement in VAS leg pain. Patients reported improvement in their physical state according to SF-12 scores (89.3% of 1-level, 88.9% of 2-level). Patient satisfaction at 60 months was 97.4% for 1-level and 93.3% for 2-level.

Conclusions

The therapeutic sustainability for the treatment of spinal stenosis without spondylolisthesis with interlaminar stabilization at 1 or 2 levels in the lumbar region has been shown to be safe and efficacious for patients who have failed conservative treatment.

Clinical Relevance

Decompression with ILS offers a new clinical continuum of care by providing a non-fusion surgical alternative.

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keywords: 
interlaminar stabilization, spinal stenosis, non-fusion surgical alternative
Volume 11 Issue 2
doi: 
10.14444/proof33