Prospective Registration Study for Establishing Minimal Clinically Important Differences in Patients Undergoing Surgery for Spinal Metastases.

STUDY DESIGN: Multicenter, prospective registry study. OBJECTIVE: To clarify minimal clinically important differences (MCIDs) for surgical interventions for spinal metastases, thereby enhancing patient care by integrating quality of life (QoL) assessments with clinical outcomes. SUMMARY OF BACKGROUND DATA: Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases. METHODS: This study included 171 (out of 413) patients from the multicenter "Prospective Registration Study on Surgery for Metastatic Spinal Tumors" by the Japan Association of Spine Surgeons. These were evaluated preoperatively and at 6 months postoperatively using the Face scale, EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), including the visual analog scale (VAS), and performance status. The MCIDs were calculated using an anchor-based method, classifying participants into the improved, unchanged, and deteriorated groups based on the Face scale scores. Focusing on the improved and unchanged groups, the change in the EQ-5D-5L values from before to after treatment was analyzed, and the cutoff value with the highest sensitivity and specificity was determined as the MCID through receiver operating characteristic curve analysis. The validity of the MCIDs was evaluated using a distribution-based calculation method for patient-reported outcomes. RESULTS: The improved, unchanged, and deteriorated groups comprised 121, 28, and 22 participants, respectively. The anchor-based MCIDs for the EQ-5D-5L index, EQ-VAS, and domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were 0.21, 15.50, 1.50, 0.50, 0.50, 0.50, and 0.50, respectively; the corresponding distribution-based MCIDs were 0.17, 15,99, 0.77, 0.80, 0.78, 0.60, and 0.70, respectively. CONCLUSION: We identified MCIDs for surgical treatment of spinal metastases, providing benchmarks for future clinical research. By retrospectively examining whether the MCIDs are achieved, factors favoring their achievement and risks affecting them can be explored. This could aid in decisions on surgical candidacy and patient counseling.

Finite Element Modeling for Biomechanical Comparisons of Multilevel Transforaminal, Posterior, and Lateral Lumbar Approaches to Interbody Fusion Augmented with Posterior Instrumentation.

OBJECTIVE: Verifying the intervertebral stability of each intervertebral fusion procedure, including transforaminal, posterior, and lateral lumbar interbody fusion (TLIF, PLIF, and LLIF, respectively), and the ratio of stress on the rods and pedicle screws during initial fixation may help select a fixation procedure that reduces the risk of mechanical complications, including rod fracture and screw loosening. Thus, we aimed to assess whether these procedures could prevent mechanical complications. METHODS: Using the finite element method (FEM), we designed 4 surgical models constructed from L2-5 as follows: posterior lumbar fusion (PLF), TLIF, PLIF, and LLIF models. Bilateral rods and each pedicle screw stress were tracked and calculated as Von Mises stress (VMS) for comparison among the PLF and other 3 interbody fusion models during flexion, extension, and side-bending movements. RESULTS: The lowest rod VMS was LLIF, followed by PLIF, TLIF, and PLF in flexion and side bending movements. Compared with PLF, intervertebral fixation significantly reduced stress on the rods. No remarkable differences were observed in extension movements in each surgical procedure. A tendency for higher pedicle screw VMS was noted at the proximal and distal ends of the fixation ranges, including L2 and L5 screws for each procedure in all motions. Intervertebral fixation significantly reduced stress on the L2 and L5 screws, particularly in LLIF. CONCLUSIONS: Stress on the rods and pedicle screws in the LLIF model was the lowest compared with that induced by other intervertebral fusion procedures. Therefore, LLIF may reduce mechanical complications occurrence, including rod fracture and screw loosening.

Comparison of the Susceptibility to Implant Failure in the Lateral, Posterior, and Transforaminal Lumbar Interbody Fusion: A Finite Element Analysis.

OBJECTIVE: There are several techniques for lumbar interbody fusion, and implant failure following lumbar interbody fusion can be troublesome. This study aimed to compare the stress in posterior implant and peri-screw vertebral bodies among lateral lumbar interbody fusion (LLIF), posterior lumbar interbody fusion (PLIF), and transforaminal lumbar interbody fusion (TLIF) and to select the technique that is least likely to cause implant failure. METHODS: We created an intact L3-L5 model and simulated the LLIF, PLIF, and TLIF techniques at L4-L5 using finite element methods. All models at the lower portion of L5 were fixed and imposed a preload of 400 N and a moment of 7.5 Nm on the upper portion of L3 to simulate flexion, extension, lateral bending, and axial rotation. We investigated the peak stresses and stress concentration in the posterior implant and peri-screw vertebral bodies for the LLIF, PLIF, and TLIF techniques. RESULTS: The extension, flexion, bending, and rotation peak stresses and stress concentration in the posterior implant, as well as the peri-screw vertebral bodies, were the lowest in LLIF, followed by PLIF and TLIF. CONCLUSIONS: It was found that implant failure was least likely to occur in LLIF, followed by PLIF and TLIF. Hence, surgeons should be aware of these factors when selecting an appropriate surgical technique and be careful for implant failure during postoperative follow-up.

Comparison of Hybrid Posterior Fixation and Conventional Open Posterior Fixation Combined with Multilevel Lateral Lumbar Interbody Fusion for Adult Spinal Deformity.

We compared radiological and clinical outcomes between multilevel lateral lumbar interbody fusion (LLIF) + hybrid posterior fixation (PF) and multilevel LLIF + conventional open PF in patients with adult spinal deformity (ASD). Patients who underwent minimally invasive surgery for ASD in a single institution between 2014 and 2018 were retrospectively reviewed. Fifty-six patients (hybrid PF, 30; open PF, 26) who underwent ASD correction surgery were enrolled between 2014 and 2018. We evaluated patients' demographics, clinical outcomes, and radiographical parameters in each group. There was significantly less estimated blood loss in the hybrid PF group (662.8 mL vs. 1088.8 mL; p = 0.012). The CRP level 7 days after surgery was significantly lower in the hybrid PF group (2.9 mg/dL vs. 4.3 mg/dL; p = 0.035). There was no significant difference between the two groups in other demographic variables, visual analog scores for back pain and leg pain, Oswestry Disability Index, coronal Cobb angle, lumbar lordosis, pelvic tilt, pelvic incidence-lumbar lordosis mismatch, and sagittal vertical axis. There was a significantly higher percentage of major complications in the open PF group (42.3% vs. 13.3%; p = 0.039). Thus, LLIF + hybrid PF for ASD corrective surgery may be comparable to LLIF + open PF in terms of clinical and radiographic outcomes.

Quantification of metal-induced susceptibility artifacts associated with ultrahigh-field magnetic resonance imaging of spinal implants.

Reports on spinal-implant metallic artifacts in 7-T magnetic resonance imaging (MRI) are lacking. Thus, we investigated the magnitude of metal artifacts derived from spinal implants in 7-T MRI and analyzed the differences obtained with spinal rods manufactured from pure titanium, titanium alloy, and cobalt-chrome (5.5-mm and 6.0-mm diameters and 50-mm length). Following the American Society for Testing and Materials guidelines, we measured the artifact size and artifact volume ratio of each rod during image acquisition using 7-T MRI scanners with three-dimensional (3D) T1-weighted and 3D T2* spoiled gradient echo (GRE), 3D T2-weighted fast spin echo, zero echo time (ZTE), and diffusion-weighted imaging sequences. Pure titanium and titanium alloy rods yielded significantly smaller artifacts than did cobalt-chrome rods, with no significant difference between pure titanium and titanium alloy rods. The artifact sizes of the 5.5-mm and 6.0-mm diameter rods were similar. The artifact magnitude increased in the following sequence order: ZTE, 3D T2 fast spin echo, 3D T1 spoiled GRE, 3D T2* spoiled GRE, and diffusion-weighted imaging. Artifacts obtained using the spin echo method were smaller than those obtained with the GRE method. Because the echo time in ZTE is extremely short, the occurrence of artifacts because of image distortion and signal loss caused by differences in magnetic susceptibility is minimal, resulting in the smallest artifacts. ZTE can be a clinically useful method for the postoperative evaluation of patients after instrumentation surgery, even with 7-T MRI.

Evaluation of the serum ionic fluoride concentration as a biomarker of bone metabolism post-spinal fusion surgery.

BACKGROUND: Bone union after spinal fusion surgery with instrumentation has been determined only with imaging studies. We evaluated the usefulness of the serum ionic fluoride (SIF) concentration as a biomarker of the bone union status. METHODS: We enrolled 25 patients who underwent spinal surgery in our institution, and we divided patients into three groups with and without instrumentation (G1, G2, and G3). We collected the fasting serum level preoperatively and on day 1 (D1), week 1 (D7), week 2 (D14), month 1 (D30), month 3 (D90), and month 6 (D180) postoperatively, and measured SIF concentrations using the flow injection method with an ion-selective electrode. RESULTS: Although preoperative SIF concentrations were similar among the 3 groups, postoperative SIF concentrations were different among the groups. SIF concentrations in groups with instrumentation (G2 and G3) increased between D14 and D90 postoperatively and decreased at D180 postoperatively. SIF concentrations in the group without instrumentation (G1) decreased between D30 and D180 postoperatively. CONCLUSIONS: An SIF concentration that is higher postoperatively than preoperatively may indicate unstable bone union, whereas a lower SIF concentration postoperatively than preoperatively may indicate stable bone union. We concluded that the SIF concentration may be useful for diagnosing bone union.

Evaluation of Water Content in Lumbar Intervertebral Discs and Facet Joints Before and After Physiological Loading Using T2 Mapping MRI.

STUDY DESIGN: T2 mapping was used to quantify the water content of lumbar spine intervertebral discs (IVDs) and facet joints before and after physiological loading. OBJECTIVE: The aim of this study was to clarify the interaction between lumbar spine IVD and facet joints as load-bearing structures by measuring the water content of their matrix after physiological loading using T2 mapping magnetic resonance imaging (MRI). SUMMARY OF BACKGROUND DATA: To date, few reports have functionally evaluated lumbar spine IVD and facet joints, and their interaction in vivo. T2 mapping may help detect changes in the water content of IVD and articular cartilage of facet joints before and after physiological loading, thereby enabling the evaluation of changes in interacted water retention between IVD and facet joints. METHODS: Twenty asymptomatic volunteers (10 female and 10 male volunteers; mean age, 19.3 years; age range, 19-20 years) underwent MRI before and after physiological loading such as lumbar flexion, extension, and rotation. Each IVD from L1/2 to L5/S1 was sliced at center of the disc space, and the T2 value was measured at the nucleus pulposus (NP), anterior annulus fibrosus (AF), posterior AF, and bilateral facet joints. RESULTS: In the NP, T2 values significantly decreased after exercise at every lumbar spinal level. In the anterior AF, there were no significant differences in T2 values at any level. In the posterior AF, T2 values significantly increased only at L4/5. In the bilateral facet joints, T2 values significantly decreased after exercise at every level. CONCLUSION: There was a significant decrease in the water content of facet joints and the NP at every lumbar spinal level after dynamic loading by physical lumbar exercise. These changes appear to play an important and interactional role in the maintenance of the interstitial matrix in the IVD NP and cartilage in the facet joint. LEVEL OF EVIDENCE: 3.

Assessment of magnetic field interactions and radiofrequency-radiation-induced heating of metallic spinal implants in 7 T field.

The safety of metallic spinal implants in magnetic resonance imaging (MRI) performed using ultrahigh fields has not been established. Hence, we examined whether the displacement forces caused by a static magnetic field and the heating induced by radiofrequency radiation are substantial for spinal implants in a 7 T field. We investigated spinal rods of various lengths and materials, a screw, and a cross-linking bridge in accordance with the American Society for Testing and Materials guidelines. The displacement forces of the metallic implants in static 7 T and 3 T static magnetic fields were measured and compared. The temperature changes of the implants during 15-min-long fast spin-echo and balanced gradient-echo image acquisition sequences were measured in the 7 T field. The deflection angles of the metallic spinal materials in the 7 T field were 5.0-21.0° [median: 6.7°], significantly larger than those in the 3 T field (1.0-6.3° [2.2°]). Among the metallic rods, the cobalt-chrome rods had significantly larger deflection angles (17.8-21.0° [19.8°]) than the pure titanium and titanium alloy rods (5.0-7.7° [6.2°]). The temperature changes of the implants, including the cross-linked rods, were 0.7-1.0°C [0.8°C] and 0.6-1.0°C [0.7°C] during the fast spin-echo and balanced gradient-echo sequences, respectively; these changes were slightly larger than those of the controls (0.4-1.1°C [0.5°C] and 0.3-0.9°C [0.6°C], respectively). All of the metallic spinal implants exhibited small displacement forces and minimal heating, indicating that MRI examinations using 7 T fields may be performed safely on patients with these implants. © 2016 The Authors. Journal of Orthopaedic Research Published by Wiley Periodicals, Inc. on behalf of Orthopaedic Research Society. J Orthop Res 35:1831-1837, 2017.

Evaluation of Water Retention in Lumbar Intervertebral Disks Before and After Exercise Stress With T2 Mapping.

STUDY DESIGN: T2 mapping was used to quantify moisture content of the lumbar spinal disk nucleus pulposus (NP) and annulus fibrosus before and after exercise stress, and after rest, to evaluate the intervertebral disk function. OBJECTIVE: To clarify water retention in intervertebral disks of the lumbar vertebrae by performing magnetic resonance imaging before and after exercise stress and quantitatively measuring changes in moisture content of intervertebral disks with T2 mapping. SUMMARY OF BACKGROUND DATA: To date, a few case studies describe functional evaluation of articular cartilage with T2 mapping; however, T2 mapping to the functional evaluation of intervertebral disks has rarely been applied. Using T2 mapping might help detect changes in the moisture content of intervertebral disks, including articular cartilage, before and after exercise stress, thus enabling the evaluation of changes in water retention shock absorber function. METHODS: Subjects, comprising 40 healthy individuals (males: 26, females: 14), underwent magnetic resonance imaging T2 mapping before and after exercise stress and after rest. Image J image analysis software was then used to set regions of interest in the obtained images of the anterior annulus fibrosus, posterior annulus fibrosus, and NP. T2 values were measured and compared according to upper vertebrae position and degeneration grade. RESULTS: T2 values significantly decreased in the NP after exercise stress and significantly increased after rest. According to upper vertebrae position, in all of the upper vertebrae positions, T2 values for the NP significantly decreased after exercise stress and significantly increased after rest. According to the degeneration grade, in the NP of grade 1 and 2 cases, T2 values significantly decreased after exercise stress and significantly increased after rest. CONCLUSION: T2 mapping could be used to not only diagnose the degree of degeneration but also evaluate intervertebral disk function. LEVEL OF EVIDENCE: 3.