Adjacent-Level Hypermobility and Instrumented-Level Fatigue Loosening With Titanium and PEEK Rods for a Pedicle Screw System: An In Vitro Study.

Adjacent-level disease is a common iatrogenic complication seen among patients undergoing spinal fusion for low back pain. This is attributed to the postsurgical differences in stiffness between the spinal levels, which result in abnormal forces, stress shielding, and hypermobility at the adjacent levels. In addition, as most patients undergoing these surgeries are osteoporotic, screw loosening at the index level is a complication that commonly accompanies adjacent-level disease. Recent studies indicate that a rod with lower rigidity than that of titanium may help to overcome these detrimental effects at the adjacent level. The present study was conducted in vitro using 12 L1-S1 specimens divided into groups of six, with each group instrumented with either titanium rods or PEEK (polyetheretherketone) rods. The test protocol included subjecting intact specimens to pure moments of 10 Nm in extension and flexion using an FS20 Biomechanical Spine Test System (Applied Test Systems) followed by hybrid moments on the instrumented specimens to achieve the same L1-S1 motion as that of the intact specimens. During the protocol's later phase, the L4-L5 units from each specimen were segmented for cyclic loading followed by postfatigue kinematic analysis to highlight the differences in motion pre- and postfatigue. The objectives included the in vitro comparison of (1) the adjacent-level motion before and after instrumentation with PEEK and titanium rods and (2) the pre- and postfatigue motion at the instrumented level with PEEK and titanium rods. The results showed that the adjacent levels above the instrumentation caused increased flexion and extension with both PEEK and titanium rods. The postfatigue kinematic data showed that the motion at the instrumented level (L4-L5) increased significantly in both flexion and extension compared to prefatigue motion in titanium groups. However, there was no significant difference in motion between the pre- and postfatigue data in the PEEK group.

Morphological changes of the caudal cervical intervertebral foramina due to flexion-extension and compression-traction movements in the canine cervical vertebral column.

BACKGROUND: Previous studies in humans have reported that the dimensions of the intervertebral foramina change significantly with movement of the spine. Cervical spondylomyelopathy (CSM) in dogs is characterized by dynamic and static compressions of the neural components, leading to variable degrees of neurologic deficits and neck pain. Studies suggest that intervertebral foraminal stenosis has implications in the pathogenesis of CSM. The dimensions of the cervical intervertebral foramina may significantly change during neck movements. This could have implication in the pathogenesis of CSM and other diseases associated with radiculopathy such as intervertebral disc disease. The purpose of this study was to quantify the morphological changes in the intervertebral foramina of dogs during flexion, extension, traction, and compression of the canine cervical vertebral column. All vertebral columns were examined with magnetic resonance imaging prior to biomechanic testing. Eight normal vertebral columns were placed in Group 1 and eight vertebral columns with intervertebral disc degeneration or/and protrusion were assigned to Group 2. Molds of the left and right intervertebral foramina from C4-5, C5-6 and C6-7 were taken during all positions and loading modes. Molds were frozen and vertical (height) and horizontal (width) dimensions of the foramina were measured. Comparisons were made between neutral to flexion and extension, flexion to extension, and traction to compression in neutral position. RESULTS: Extension decreased all the foraminal dimensions significantly, whereas flexion increased all the foraminal dimensions significantly. Compression decreased all the foraminal dimensions significantly, and traction increased the foraminal height, but did not significantly change the foraminal width. No differences in measurements were seen between groups. CONCLUSIONS: Our results show movement-related changes in the dimensions of the intervertebral foramina, with significant foraminal narrowing in extension and compression.

Effects of flexion and extension on the diameter of the caudal cervical vertebral canal in dogs.

OBJECTIVE: To quantify changes in the diameter of the vertebral canal with flexion and extension in the cervical vertebral column. STUDY DESIGN: Cadaveric biomechanical study. SAMPLE POPULATION: Cadaveric canine cervical vertebral column (n = 16 dogs). METHODS: All vertebral columns were evaluated with MRI. Group 1 consisted of 8 normal vertebral columns. Group 2 included 8 vertebral columns with intervertebral disc degeneration. Flexion, extension, compression, and tension were applied to the caudal cervical region (C4-5, C5-6, C6-7). Sagittal vertebral canal diameters (VCD) were obtained by measuring the distance between the ventral and dorsal aspects of vertebral canal. RESULTS: No differences were seen between groups, thus the results are for both groups. Comparison of VCD between flexion and extension with no load revealed a difference of 2.2 mm (28.9%; P < .001). Comparison between neutral position and extension revealed a reduction of 1.5 mm (16.5%; P < .001), whereas comparison between neutral and flexion showed an increase of 0.7 mm (7.7%; P = .001) in VCD. Comparison between neutral with no load and neutral with compression showed a difference of 0.5 mm, with reduction of 5.5% in the vertebral canal (P = .006). Comparison of extension with no load versus extension with tension revealed an increase of 0.7 mm (9.2%) in the vertebral canal (P < .001). CONCLUSIONS: Cervical vertebral canal diameter decreased significantly with extension and increased with flexion. The results support the presence of dynamic impingement possibly playing a role in diseases characterized by vertebral canal stenosis, such as cervical spondylomyelopathy.

Validation of a patient-specific finite element analysis framework for identification of growing rod-failure regions in early onset scoliosis patients.

PURPOSE: Growing rods are the gold-standard for treatment of early onset scoliosis (EOS). However, these implanted rods experience frequent fractures, requiring additional surgery. A recent study by the U.S. Food and Drug Administration (FDA) identified four common rod fracture locations. Leveraging this data, Agarwal et al. were able to correlate these fractures to high-stress regions using a novel finite element analysis (FEA) framework for one patient. The current study aims to further validate this framework through FEA modeling extended to multiple patients. METHODS: Three patient-specific FEA models were developed to match the pre-operative patient data taken from both registry and biplanar radiographs. The surgical procedure was then simulated to match the post-operative deformity. Body weight and flexion bending (1 Nm) loads were then applied and the output stress data on the rods were analyzed. RESULTS: Radiographic data showed fracture locations at the mid-construct, adjacent to the distal and tandem connector across the patients. Stress analysis from the FEA showed these failure locations matched local high-stress regions for all fractures observed. These results qualitatively validate the efficacy of the FEA framework by showing a decent correlation between localized high-stress regions and the actual fracture sites in the patients. CONCLUSIONS: This patient-specific, in-silico framework has huge potential to be used as a surgical tool to predict sites prone to fracture in growing rod implants. This prospective information would therefore be vital for surgical planning, besides helping optimize implant design for reducing rod failures.

Biomechanical Effects of Thoracic Flexibility and Stiffness on Lumbar Spine Loading: A Finite Element Analysis Study.

OBJECTIVE: To determine the effects of thoracic stiffness on mechanical stress in the lumbar spine during motion. METHODS: To evaluate the effect of preoperative thoracic flexibility, stiff and flexible spine models were created by changing the material properties of ligaments and discs in the thoracic spine. Total laminectomy was performed at L4/5 in stiff and flexible models. A biomechanical investigation and finite element analysis were performed preoperatively and postoperatively. A hybrid loading condition was applied, and the range of motion (ROM) at each segment and maximum stress in the discs and pars interarticularis were computed. RESULTS: In the preoperative model with the stiff thoracic spine, lumbar disc stress, lumbar ROM, and pars interarticularis stress at L5 increased. In contrast, as the thoracic spine became more flexible, lumbar disc stress, lumbar ROM, and pars interarticularis stress at L5 decreased. All L4/5 laminectomy models had increased instability and ROM at L4/5. To evaluate the effect of thoracic flexibility on the lumbar spine, differences between the stiff and flexible thoracic spine were examined: Differences in ROM and intervertebral disc stress at L4/5 in flexion between the stiff and flexible thoracic spine were respectively 0.7° and 0.0179 MPa preoperatively and 1.5° and 0.0367 MPa in the L4/5 laminectomy model. CONCLUSIONS: Biomechanically, disc stress and pars interarticularis stress decrease in the flexible thoracic spine. Flexibility of the thoracic spine reduces lumbar spine loading and could help to prevent stress-related disorders.

Resisting subsidence with a truss Implant: Application of the "Snowshoe" principle for interbody fusion devices.

The primary objective was to compare the subsidence resistance properties of a novel 3D-printed spinal interbody titanium implant versus a predicate polymeric annular cage. We evaluated a 3D-printed spinal interbody fusion device that employs truss-based bio-architectural features to apply the snowshoe principle of line length contact to provide efficient load distribution across the implant/endplate interface as means of resisting implant subsidence. Devices were tested mechanically using synthetic bone blocks of differing densities (osteoporotic to normal) to determine the corresponding resistance to subsidence under compressive load. Statistical analyses were performed to compare the subsidence loads and evaluate the effect of cage length on subsidence resistance. The truss implant demonstrated a marked rectilinear increase in resistance to subsidence associated with increase in the line length contact interface that corresponds with implant length irrespective of subsidence rate or bone density. In blocks simulating osteoporotic bone, comparing the shortest with the longest length truss cage (40 vs. 60 mm), the average compressive load necessary to induce subsidence of the implant increased by 46.4% (383.2 to 561.0 N) and 49.3% (567.4 to 847.2 N) for 1 and 2 mm of subsidence, respectively. In contrast, for annular cages, there was only a modest increase in compressive load when comparing the shortest with the longest length cage at a 1 mm subsidence rate. The Snowshoe truss cages demonstrated substantially more resistance to subsidence than corresponding annular cages. Clinical studies are required to support the biomechanical findings in this work.

C1-C2 arthroplasty for craniovertebral junction instability: A preliminary proof of concept in human cadavers.

Background: The atlantoaxial complex contributes to significant neck movements, especially the axial rotation. Its instability is currently treated with various C1-C2 fusion techniques. This however, considerably hampers the neck movements and affects the quality of life; a C1-C2 motion preserving arthroplasty could potentially overcome this drawback. Objectives: We evaluate the range of motion (ROM) of lateral C1-C2 artificial joints in cadaveric models. Materials and Methods: This is an in vitro cadaveric biomechanical study. After C1-C2 arthroplasty through a posterior approach, the C1-C2 ROM was tested in 4 fresh-frozen human cadaveric specimens, before and after destabilization. Results: The mean axial rotation demonstrated after the placement of C1-C2 joint implants was 15.46 degrees on the right and 16.03 degrees on the left side; the prosthesis provided stability, with 46% of the baseline C1-C2 axial rotation on either side. The ROM achieved in the other axes was less compared with that of intact specimens. To initiate rotation, a higher moment of 1.5 Nm was required in the presence of joint implants compared to 0.5 NM in unimplanted specimens. Conclusions: In our preliminary ROM evaluation, the C1-C2 arthroplasty appears to be stable and provides about half of the range of atlantoaxial rotation. It has the potential for joint motion preservation in the treatment of atlantoaxial instability resulting from lateral C1-C2 joint pathologies.

Finite Element Comparison of the Spring Distraction System and the Traditional Growing Rod for the Treatment of Early Onset Scoliosis.

STUDY DESIGN: Finite element analysis (FEA). OBJECTIVE: The aim of this study was to determine biomechanical differences between traditional growing rod (TGR) and spring distraction system (SDS) treatment of early-onset scoliosis. SUMMARY OF BACKGROUND DATA: Many "growth-friendly" implants like the TGR show high rates of implant failure, spinal stiffening, and intervertebral disc (IVD) height loss. We developed the SDS, which employs continuous, dynamic forces to mitigate these limitations. The present FEA compares TGR and SDS implantation, followed by an 18-month growth period. METHODS: Two representative, ligamentous, scoliotic FEA models were created for this study; one representing TGR and one representing SDS. initial implantation, and up to 18 months of physeal spinal growth were simulated. The SDS model was continuously distracted over this period; the TGR model included two additional distractions following index surgery. Outcomes included differences in rod stress, spinal morphology and iVD stress-shielding. RESULTS: Maximum postoperative von Mises stress was 249MPa for SDS, and 205MPa for TGR. During the 6-month TGR distraction, TGR rod stress increased over two-fold to a maximum stress of 417MPa, compared to a maximum of 262 MPa in the SDS model at 6-month follow-up. During subsequent follow-up periods, TGR rod stress remained consistently higher than stresses in the SDS model. Additional lengthenings in the TGR model led to a smaller residual curve (16.08) and higher T1-S1 growth (359 mm) at 18-month follow-up compared to the SDS model (26.98, 348 mm). During follow-up, there was less stress-shielding of the IVDs in the SDS model, compared to the TGR model. At 18-month follow-up, upper and lower IVD surfaces of the SDS model were loaded more in compression than their TGR counterparts (mean upper: +112 ±â€Š19N; mean lower: +100 ±â€Š17N). CONCLUSION: In the present FEA, TGR treatment resulted in slightly larger curve correction compared to SDS, at the expense of increased IVD stress-shielding and a higher risk of rod fractures. LEVEL OF EVIDENCE: N/A.

Towards a validated patient-specific computational modeling framework to identify failure regions in traditional growing rods in patients with early onset scoliosis.

BACKGROUND: While growing rods are an important contribution to early-onset scoliosis treatment, rod fractures are a common complication that require reoperations. A recent retrieval analysis study performed on failed traditional growing rods revealed that there are commonalities among patient characteristics based on the location of rod fracture. However, it remains unknown if these locations correspond to high stress regions in the implanted construct. METHODS: A patient-specific finite element scoliotic model was developed to match the pre-operative (pre-op) scoliotic curve of a patient as described in previously published articles, and by using the patient registry information along with biplanar radiographs. A dual stainless-steel traditional growing rod construct was implanted into this scoliotic model and the surgical procedure was simulated to match the post-operative (post-op) scoliotic curve parameters. Muscle stabilization and gravity was simulated through follower load application. Rod distraction magnitudes were chosen based on pre-op to post-op cobb angle correction, and flexion bending load was simulated to identify the high stress regions on the rods. RESULTS: The patient-specific finite element model identified two high stress regions on the posterior surface of the rods, one at mid construct and the other adjacent to the distal anchors. This correlated well with the data obtained from the retrieval analysis performed by researchers at U.S. Food and Drug Administration (FDA) which showed the posterior surface of the rod as the fracture initiation site, and the three locations of failure as mid-construct, adjacent to distal anchors, and adjacent to tandem connector. CONCLUSIONS: The result of this study confirms that the high stress regions on the growing rods, as identified by the FEA, match the fracture prone sites identified in the retrieval analysis performed at the FDA. This proof-of-concept patient-specific approach can be used to predict sites prone to fracture in growing rods.

The Transverse Process Trajectory Technique: An Alternative for Thoracic Pedicle Screw Implantation-Radiographic and Biomechanical Analysis.

BACKGROUND: This study evaluates the accuracy, biomechanical profile, and learning curve of the transverse process trajectory technique (TPT) compared to the straightforward (SF) and in-out-in (IOI) techniques. SF and IOI have been used for fixation in the thoracic spine. Although widely used, there are associated learning curves and symptomatic pedicular breaches. We have found the transverse process to be a reproducible pathway into the pedicle. METHODS: Three surgeons with varying experience (experienced [E] with 20 years in practice, surgeon [S] with less than 10 years in practice, and senior resident trainee [T] with no experience with TPT) operated on 8 cadavers. In phase 1, each surgeon instrumented 2 cadavers, alternating between TPT and SF from T1 to T12 (n = 48 total levels). In phase 2, the E and T surgeons instrumented 1 cadaver each, alternating between TPT and IOI. Computed tomography scans were analyzed for accuracy of screw placement, defined as the percentage of placements without critical breaches. Axial pullout and derotational force testing were performed. Statistical analyses include paired t test and analysis of variance with Tukey correction. RESULTS: Overall accuracy of screw placement was comparable between techniques (TPT: 92.7%; SF: 97.2%; IOI: 95.8%; P = .4151). Accuracy by technique did not differ for each individual surgeon (E: P = .7733; S: P = .3475; T: P = .4191) or by experience level by technique (TPT: P = .1127; FH: P = .5979; IOI: P = .5935). Pullout strength was comparable between TPT and SF (571 vs 442 N, P = .3164) but was greater for TPT versus IOI (454 vs 215 N, P = .0156). There was a trend toward improved derotational force for TPT versus SF (1.06 vs 0.93 Nm/degrees, P = .0728) but not for TPT versus IOI (1.36 vs 1.16 Nm/degrees, P = .74). Screw placement time was shortest for E and longest for T for TPT and SF and not different for IOI (TPT: P = .0349; SF: P < .0001; IOI: P = .1787) but did not vary by technique. CONCLUSIONS: We describe the TPT, which uses the transverse process as a corridor through the pedicle. TPT is an accurate method of thoracic pedicle screw placement with potential biomechanical advantages and with acceptable learning curve characteristics. CLINICAL RELEVANCE: This study provides the surgeon with a new trajectory for pedicle screw placement that can be used in clinical practice.

A new lumbar fixation device alternative to pedicle-based stabilization for lumbar spine: In vitro cadaver investigation.

Context: To evaluate the stability provided by a new bilateral fixation technique using an in vitro investigation for posterior lumbar segmental instrumentation.Design: Experimental cadaver study. In this study, we propose an alternative technique for a posterior lumbar fixation technique called "inferior-oblique transdiscal fixation" (IOTF).Setting: Study performed at Engineering Center for Orthopedic Research Exellence (ECORE) in Toledo University-Ohio.Participants: Six human lumbar cadaveric specimen used in this study.Interventions: In this study, we propose an alternative technique for a posterior lumbar fixation technique called "inferior-oblique transdiscal fixation" (IOTF). As a novel contribution to the classical technique, the entry point of the screw is the supero-lateral point of the intersecting line drawn between the corpus and the pedicle of the upper vertebra. This approach enables the fixation of two adjacent vertebrae using a single screw on each side without utilizing connecting rods.Outcome Measures: Flexion (Flex), extension (Ext), right and left lateral bending (LB & RB), and right and left axial rotation (LR & RR), and the position data were captured at each load step using the Optotrak motion measurement system and compared for IOTF and posterior transpedicular stabilization.Results: The Posterior stabilization system (PSS) and IOTF significantly reduced the ROM of L4-L5 segment compared to intact segment's ROM. During axial rotation (AR) IOTF fused index segment more than PSS. Besides this, addition of transforaminal lumbar interbody fusion (TLIF) cage improved the stabilization of IOTF system during flexion, extension and lateral bending. Whereas, PSS yielded better fusion results during extension compared to IOTF with and without interbody fusion cages.Conclusions: We hypothesized that the new posterior bilateral system would significantly decrease motion compared to the intact spine. This cadaver study showed that the proposed new posterior fusion technique IOTF fused the index segment in a similar fashion to the classical pedicle screw fusion technique.

Does Spanning a Lateral Lumbar Interbody Cage Across the Vertebral Ring Apophysis Increase Loads Required for Failure and Mitigate Endplate Violation.

STUDY DESIGN: Randomized Biomechanical Cadaveric Study-Level II. OBJECTIVE: We aimed to elucidate that placing lateral lumbar interbody cages that span the stronger ring apophysis will require increasing loads for failure, decreasing rates of subsidence, regardless of bone density or endplate integrity. SUMMARY OF BACKGROUND DATA: There are several reports regarding the rates and grades of cage subsidence when utilizing the lateral lumbar interbody fusion technique. However, there is limited data on how spanning the lateral cage across the ring apophysis can prevent it. METHODS: Eight fresh-frozen human spines (L1-L5) were utilized. Each vertebra was placed with their endplates horizontal in an MTS actuator. A total of 40 specimens were randomized into Groups:Load displacement data was collected at 5 Hz until failure. RESULTS: Longer cages spanning the ring apophysis provided more strength in compression with less subsidence relative to shorter cages, regardless of endplate integrity.Longer cages, spanning the ring apophysis, resting on intact endplates (G2) had a significant (P < 0.05) increase in strength and less subsidence when compared with the smaller cage group resting on intact endplates (G1) (P = 0.003).Longer cages spanning the ring apophysis of intact endplates (G2) showed a significant (P < 0.05) increase in strength and resistance to subsidence when compared with similar length cages resting on decorticated endplates (G4) (P = 0.028). CONCLUSION: Spanning the ring apophysis increased the load to failure by 40% with intact endplates and by 30% with decorticated endplates in this osteoporotic cadaveric model. Larger cages that span the endplate ring apophysis could improve the compressive strength and decrease subsidence at the operative level despite endplate violation or osteoporosis. LEVEL OF EVIDENCE: 2.