Biomechanical Evaluation of the Lumbar Spine by Using a New Interspinous Process Device: A Finite Element Analysis

Minimally invasive decompression is generally employed for treating lumbar spinal stenosis; however, it results in weakened spinal stability. To augment spinal stability, a new interspinous process device (NIPD) was developed in this study. The biomechanical features of the NIPD were evaluated in this study. Three finite-element (FE) models of the entire lumbar spine were implemented to perform biomechanical analysis: the intact, defect (DEF), and NIPD models. The DEF model was considered for lumbar spines with bilateral laminotomies and partial discectomy at L3–L4. Range of motion (ROM), disc stress, and facet joint contact force were evaluated in flexion, extension, torsion, and lateral bending in the three FE models. The results indicated that ROM in the extension increased by 23% in the DEF model but decreased by 23% in the NIPD model. In the NIPD model, the cephalic adjacent disc stress in flexion and extension was within 5%, and negligible changes were noted in the facet joint contact force for torsion and lateral bending. Thus, the NIPD offers superior spinal stability and causes only a minor change in cephalic adjacent disc stress in flexion and extension during the bilateral laminotomy and partial discectomy of the lumbar spine. However, the NIPD has a minor influence on the ROM and facet joint force for lateral bending and torsion.

Biomechanical analysis of a newly developed interspinous process device conjunction with interbody cage based on a finite element model

Purpose This study aimed to investigate the biomechanical effects of a newly developed interspinous process device (IPD), called TAU. This device was compared with another IPD (SPIRE) and the pedicle screw fixation (PSF) technique at the surgical and adjacent levels of the lumbar spine. Materials and methods A three-dimensional finite element model analysis of the L1-S1 segments was performed to assess the biomechanical effects of the proposed IPD combined with an interbody cage. Three surgical models—two IPD models (TAU and SPIRE) and one PSF model—were developed. The biomechanical effects, such as range of motion (ROM), intradiscal pressure (IDP), disc stress, and facet loads during extension were analyzed at surgical (L3-L4) and adjacent levels (L2-L3 and L4-L5). The study analyzed biomechanical parameters assuming that the implants were perfectly fused with the lumbar spine. Results The TAU model resulted in a 45%, 49%, 65%, and 51% decrease in the ROM at the surgical level in flexion, extension, lateral bending, and axial rotation, respectively, when compared to the intact model. Compared to the SPIRE model, TAU demonstrated advantages in stabilizing the surgical level, in all directions. In addition, the TAU model increased IDP at the L2-L3 and L4-L5 levels by 118.0% and 78.5% in flexion, 92.6% and 65.5% in extension, 84.4% and 82.3% in lateral bending, and 125.8% and 218.8% in axial rotation, respectively. Further, the TAU model exhibited less compensation at adjacent levels than the PSF model in terms of ROM, IDP, disc stress, and facet loads, which may lower the incidence of the adjacent segment disease (ASD). Conclusion The TAU model demonstrated more stabilization at the surgical level than SPIRE but less stabilization than the PSF model. Further, the TAU model demonstrated less compensation at adjacent levels than the PSF model, which may lower the incidence of ASD in the long term. The TAU device can be used as an alternative system for treating degenerative lumbar disease while maintaining the physiological properties of the lumbar spine and minimizing the degeneration of adjacent segments.

Axial loading during MRI reveals insufficient effect of percutaneous interspinous implants (Aperius™ PerCLID™) on spinal canal area

Purpose To evaluate the effect on the spinal canal at the treated and adjacent level(s), in patients treated for lumbar spinal stenosis (LSS) with percutaneous interspinous process device (IPD) Aperius™ or open decompressive surgery (ODS), using axial loading of the spine during MRI (alMRI). Materials Nineteen LSS patients (mean age 67 years, range 49–78) treated with IPDs in 29 spine levels and 13 LSS patients (mean age 63 years, range 46–76) operated with ODS in 22 spine levels were examined with alMRI pre- and 3 months postoperatively. Radiological effects were evaluated by measuring the dural sac cross-sectional area (DSCSA) and by morphological grading of nerve root affection. Results For the IPD group, no DSCSA increase was observed at the operated level (p = 0.42); however, a decrease was observed in adjacent levels (p = 0.05). No effect was seen regarding morphological grading (operated level: p = 0.71/adjacent level: p = 0.94). For the ODS group, beneficial effects were seen for the operated level, both regarding DSCSA (p < 0.001) and for morphological grading (p < 0.0001). No changes were seen for adjacent levels (DSCSA; p = 0.47/morphological grading: p = 0.95). Postoperatively, a significant difference between the groups existed at the operated level regarding both evaluated parameters (p < 0.003). Conclusions With the spine imaged in an axial loaded position, no significant radiological effects of an IPD could be detected postoperatively at the treated level, while increased DSCSA was displayed for the ODS group. In addition, reduced DSCSA in adjacent levels was detected for the IPD group. Thus, the beneficial effects of IPD implants on the spinal canal must be questioned. Graphic abstract These slides can be retrieved under Electronic Supplementary Material.

Reduction in adjacent-segment degeneration after multilevel posterior lumbar interbody fusion with proximal DIAM implantation

OBJECTMultilevel long-segment lumbar fusion poses a high risk for future development of adjacent-segment degeneration (ASD). Creating a dynamic transition zone with an interspinous process device (IPD) proximal to the fusion has recently been applied as a method to reduce the occurrence of ASD. The authors report their experience with the Device for Intervertebral Assisted Motion (DIAM) implanted proximal to multilevel posterior lumbar interbody fusion (PLIF) in reducing the development of proximal ASD.METHODSThis retrospective study reviewed 91 cases involving patients who underwent 2-level (L4–S1), 3-level (L3–S1), or 4-level (L2–S1) PLIF. In Group A (42 cases), the patients received PLIF only, while in Group B (49 cases), an interspinous process device, a DIAM implant, was put at the adjacent level proximal to the PLIF construct. Bone resection at the uppermost segment of the PLIF was equally limited in the 2 groups, with preservation of the upper portion of the spinous process/lamina and the attached supraspinous ligament. Outcome measures included a visual analog scale (VAS) for low-back pain and leg pain and the Oswestry Disability Index (ODI) for functional impairment. Anteroposterior and lateral flexion/extension radiographs were used to evaluate the fusion status, presence and patterns of ASD, and mobility of the DIAM-implanted segment.RESULTSSolid interbody fusion without implant failure was observed in all cases. Radiographic ASD occurred in 20 (48%) of Group A cases and 3 (6%) of Group B cases (p < 0.001). Among the patients in whom ASD was identified, 9 in Group A and 3 in Group B were symptomatic; of these patients, 3 in Group A and 1 in Group B underwent a second surgery for severe symptomatic ASD. At 24 months after surgery, Group A patients fared worse than Group B, showing higher mean VAS and ODI scores due to symptoms related to ASD. At the final follow-up evaluations, as reoperations had been performed to treat symptomatic ASD in some patients, significant differences no longer existed between the 2 groups. In Group B, flexion/extension mobility at the DIAM-implanted segment was maintained in 35 patients and restricted or lost in 14 patients, 5 of whom had already lost segmental flexion/extension mobility before surgery. No patient in Group B developed ASD at the segment proximal to the DIAM implant.CONCLUSIONSProviding a dynamic transition zone with a DIAM implant placed immediately proximal to a multilevel PLIF construct was associated with a significant reduction in the occurrence of radiographic ASD, compared with PLIF alone. Given the relatively old age and more advanced degeneration in patients undergoing multilevel PLIF, this strategy appears to be effective in lowering the risk of clinical ASD and a second surgery subsequent to PLIF.