One Year Outcomes From a Prospective Multicenter Investigation Device Trial of a Novel Conformal Mesh Interbody Fusion Device

Joseph Driver, MD; Kevin T. Huang, MD; Martin Krag, MD; Mohamad Bydon, MD; Pierce Nunley, MD; Stephane Lavoie, MD; Yi Lu, MD; Marcus Stone, PhD; John H. Chi, MD, MPH

Disclosures

Spine. 2021;46(2):E126-E132. 

In This Article

Abstract and Introduction

Abstract

Study Design: A prospective multicenter investigational device exempt trial is underway evaluating a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease. Patients meeting inclusion and exclusion criteria were offered enrollment. There is no comparative group in this study.

Objective: Establish the short and long-term safety and effectiveness of a novel conformable mesh interbody fusion device in subjects undergoing single-level fusion for degenerative disc disease unresponsive to conservative care.

Summary of Background Data: Transforaminal lumbar interbody fusion remains a critical procedure for patients with degenerative lumbar disc disease. Increasingly minimally invasive techniques have been proposed to minimize muscle dissection and tissue damage with the goal of minimizing pain and length of stay.

Methods: One hundred two subjects were enrolled across 10 sites. Ninety nine subjects remained available for follow-up at 12-months. Physical evaluations/imaging were performed serially through 12-months. Validated assessment tools included 100 mm visual analogue scale (VAS) for pain, Oswestry Disability Index (ODI) for function, and computerized tomography scan for fusion. Independent committees were used to identify adverse events and for assessment of radiographic fusion.

Results: Reductions in low back pain (LBP)/leg pain and improvements in functional status occur early and are maintained through 12-month follow-up. Mean VAS-LBP change from baseline to 6-weeks post-op (–46 mm) continued to improve through 12 months (–51 mm). Similar trends were observed for leg pain. Mean ODI change from baseline to 6 weeks post-op (–17) was almost doubled by 12 months (–32). Fusion rates at 12-months are high (98%). No device-related serious adverse events have occurred.

Conclusion: 12-month outcomes demonstrated excellent patient compliance and positive outcomes for pain, function, fusion, and device safety. Clinical improvements were observed by 6-weeks post-op and appear durable up to 1 year later. A novel mesh interbody device may provide an alternative means of interbody fusion that reduces connective tissue disruption.

Level of Evidence: 3

Introduction

With the advent of minimally invasive surgery (MIS) techniques for lumbar spine surgery, there has been an increased interest in methods to accomplish transforaminal lumbar interbody fusion (TLIF) with minimal muscle dissection, bony drilling, and nerve retraction, yet provide biomechanical stability. Often, these techniques, under the umbrella term MIS-TLIF still require removal of the facet joint to insert the interbody cage, necessitating a significant degree of tissue disruption that can contribute to patient morbidity and satisfaction.[1,2]

Endoscopic and percutaneous techniques for lumbar discectomies and decompression have shown great promise in recent years.[3–6] As these techniques have grown in acceptance and sophistication, there has been an increased interest in using these techniques as the platform for the deployment of an interbody spacer. The ideal characteristics of such an implant would include the ability to (1) fit the interbody device through as small a portal as possible, and (2) deploy the device to maximize contact surface area with the adjoining vertebral endplates and restore disc height. Recently, such techniques and technologies have become available,[7,8] but data on clinical outcomes, and long-term follow-up in particular, remains limited.

Here we review the 12-month outcomes of a prospective, multicenter, food and drug administration (FDA) approved single-arm clinical investigation (NCT02347410). The goal of this study was/is to establish the safety and efficacy of the Spineology Interbody Fusion System (SIFS) in treating patients requiring single-level TLIF for single-level lumbar degenerative disc disease. The SIFS mesh is a graft containment and reinforcement device (Figure 1). Following conventional interbody discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed, and then filled with bone graft. This early analysis evaluates the results of patient outcomes up to 12 months for follow-up compliance, self-reported scores consisting of Oswestry Disability Index (ODI) and low-back pain and leg pain visual analog scale (VAS).

Figure 1.

Optimesh expandable mesh bag system. On the left, one sees the meshed bag system and its small diameter (7 mm). On the right, once it is filled with allograft and/or autograft it can be expanded to fill the natural crevices in the disc space after performing discectomy. From Zheng et al 24 with permission.

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