Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance

Overview

Journal Int J Spine Surg

Date 2020 Oct 30

PMID 33122186

Citations 3

Authors

Domagoj Coric

Raphael R Roybal

Mark Grubb

Vincent Rossi

Alex K Yu

Isaac R Swink

Jason Long

Boyle C Cheng

Jason A Inzana

Affiliations

Soon will be listed here.

Abstract

Background: Expandable devices for transforaminal or posterior lumbar interbody fusion (TLIF and PLIF, respectively) may enable greater restoration of disc height, foraminal height, and stability within the interbody space than static spacers. Medial-lateral expansion may also increase stability and resistance to subsidence. This study evaluates the clinical and radiographic outcomes from early experience with a bidirectional expandable device.

Methods: This was a retrospective analysis of a continuous series of patients across 3 sites who had previously undergone TLIF or PLIF surgery with a bidirectional expandable interbody fusion device (FlareHawk, Integrity Implants, Inc) at 1 or 2 contiguous levels between L2 and S1. Outcomes included the Oswestry Disability Index (ODI), a visual analog scale (VAS) for back pain or leg pain, radiographic fusion by 1 year of follow-up, subsidence, device migration, and adverse events (AE).

Results: There were 58 eligible patients with radiographs for 1-year fusion assessments and 45 patients with ODI, VAS back pain, or VAS leg pain data at baseline and a mean follow-up of 4.5 months. The ODI, VAS back pain, and VAS leg pain scores improved significantly from baseline to final follow-up, with mean improvements of 14.6 ± 19.1, 3.4 ± 2.6, and 3.9 ± 3.4 points ( < .001 for each), respectively. In addition, 58% of patients achieved clinically significant improvements in ODI, 76% in VAS back pain, and 71% in VAS leg pain. By 1 year, 96.6% of patients and 97.4% of levels were considered fused. There were zero cases of device subsidence and 1 case of device migration (1.7%). There were zero device-related AEs, 1 intraoperative dural tear, and 3 subsequent surgical interventions.

Conclusions: The fusion rate, improvements in patient-reported outcomes, and the AEs observed are consistent with those of other devices. The bidirectional expansion mechanism may provide other important clinical value, but further studies will be required to elucidate the unique advantages.

Level Of Evidence: 4.

Citing Articles

Exploring the differences in radiologic and clinical outcomes of transforaminal lumbar interbody fusion with single- and bi-planar expandable cages: a systematic review and meta-analysis.

Matsoukas S, Karabacak M, Margetis K Neurosurg Rev. 2024; 47(1):36.

PMID: 38191751 DOI: 10.1007/s10143-023-02277-w.

Transforaminal lumbar interbody fusion with an expandable interbody device: Two-year clinical and radiographic outcomes.

Weinstein M, Ayala G, Roura R, Christmas K, Warren D, Simon P N Am Spine Soc J. 2023; 16:100286.

PMID: 38025939 PMC: 10652136. DOI: 10.1016/j.xnsj.2023.100286.

Biplanar Expandable Cages for Transforaminal Lumbar Interbody Fusion Are Safe and Achieve Good 1-Year Clinical and Radiological Outcomes in an Asian Population.

Sim D, Kasivishvanaath A, Jiang L, Soh R, Ling Z Int J Spine Surg. 2023; 17(4):520-525.

PMID: 37076255 PMC: 10478701. DOI: 10.14444/8472.

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