Document Type

Conference Proceeding

Publication Date

5-2023

Publication Title

Journal of Neurosurgery. Spine

Abstract

Background/Introduction

Introduction. Durable surgical outcome for patients with degenerative spondylolisthesis (DS) usually requires decompression and fusion. An FDA IDE study (NCT03115983) compares direct surgical decompression and stabilization with a novel dynamic sagittal tether (Limiflex, Empirical Spine) (DST) to decompression and instrumented TLIF for symptomatic DS. Aim. Compare clinical outcomes of DST and TLIF to 4 years for symptomatic degenerative spondylolisthesis.

Materials/Methods

Patients and Methods. All patients had DS and spinal canal stenosis with ODI≥35 and VAS-leg/hip≥50 (full eligibility criteria at clinicaltrials.gov, NCT03115983). Patients received a decompression and DST or TLIF at the level of DS, with or without an adjacent level decompression if indicated. Clinical outcomes were collected through 4 year follow-up. The group reported on here is comprised of those patients from the trial who had ODI follow-up at 4 years.

Results

Results. 299 patients were enrolled in the IDE trial, and of these at the time of this submission, 72 patients (43 DST and 29 TLIF) had 4 year ODI scores. Results are reported here with 95%CI's. At 48 months, preop ODI scores decreased from a mean of 53.1 DST and 53.2 TLIF to 15.9 (22.2, 9.7) and 22.0 (29.1, 14.9). Leg pain VAS scores improved from a baseline of 79.5 and 81.2 to a mean of 28.7 and 26.2 in the DST and TLIF groups. Back pain VAS scores improved from a baseline of 68.2 and 74.9 to a mean of 22.3 and 28.0. In the DST and TLIF groups. There were 5 reoperations at the index or adjacent segment within 48 months in each group, 11.6% DST and 17.2% TLIF.

Discussion/Conclusion

Conclusions. In this cohort of patients with 4 years of clinical follow-up, patients in the experimental group had quicker improvement in their functional scores when compared to the patients undergoing fusion, with lower observed reoperation rates within the first 4 postoperative years. This data supports the idea that lasting clinical improvement, similar to that of a fusion for this condition, can be obtained with a decompression and the DST device. Further follow-up from the entire cohort of patients in the IDE will be presented once that data is available.

Volume

38

Issue

5

First Page

50

Comments

Lumbar Spine Research Society 16th Annual Scientific Meeting, May 11-12, 2023, Chicago, IL

Last Page

51

DOI

10.3171/2023.5.LSRS2023abstracts

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