Document Type

Conference Proceeding

Publication Date


Publication Title

Journal of Neurosurgery. Spine



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.


Patients and Methods. All patients had DS and spinal canal stenosis with ODI≥35 and VAS-leg/hip≥50 (full eligibility criteria at, 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. 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.


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.





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

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