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.

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.

High Prevalence of Biofilms on Retrieved Implants from Aseptic Pseudarthrosis Cases.

INTRODUCTION: Recent literature has associated pseudarthrosis and pedicle screw loosening with subchronic infection at the pedicle of the vertebra. The positive culture results of a previous retrieval analysis show that such patients have a high frequency of bacterial contamination. The objective of this study is to visually capture the architecture of these undiagnosed infections, which have been described in other studies as biofilms on supposedly "aseptic" screw loosening. METHODS: Explants from 10 consecutive patients undergoing revision spine surgery for pseudarthrosis were collected and fixed in glutaraldehyde solution. Each of these implants was imaged thoroughly by using scanning electron microscopy and x-ray spectroscopy to evaluate the architecture of the biofilm. Additionally, eight patient swabs from tissues around the implants were sent for cultures to assess bacterial infiltration in tissues beyond the biofilm. The implants were also analyzed using energy dispersive x-ray spectroscopy. The exclusion criteria included clinically diagnosed infection (current or previous) and/or mechanical failure of the implant due to falls/accidents. RESULTS: The study was successful in capturing the visual architecture of the biofilm on retrieved implants. A total of 77% of pseudarthrosis cases presented with loose pedicle screws, which were diagnosed by a preoperative computed tomography scan showing radiolucency along the screw track and were confirmed intraoperatively, and 72% of the cases showed biofilm on explants. CONCLUSIONS: In the absence of the clinical presentation of infection, impregnated bacteria could form a biofilm around an implant, and this biofilm can remain undetected via contemporary diagnostic methods, including swabbing. Implant biofilm is frequently present in "aseptic" pseudarthrosis cases.

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.

Implant Retention or Removal for Management of Surgical Site Infection After Spinal Surgery.

STUDY DESIGN: A literature review. OBJECTIVE: To summarize the implant removal rate, common bacterial organisms found, time of onset, ratio of superficial to deep infection, and regurgitating the prevalence among all the retrospective and prospective studies on management and characterization of surgical site infections (SSIs). METHODS: PubMed was searched for articles published between 2000 and 2018 on the management or characterization of SSIs after spinal surgery. Only prospective and retrospective studies were included. RESULTS: A total of 49 articles were found relevant to the objective. These studies highlighted the importance of implant removal to avoid recurrence of SSI. The common organisms detected were methicillin-resistant Staphylococcus aureus, methicillin-resistant Staphylococcus epidermis, Staphylococcus epidermis, Staphylococcus aureus, and Propionibacterium acnes, with prevalence of 1% to 15%. A major proportion of all were deep SSI, with minority reporting on late-onset SSI. CONCLUSION: Long-term antibiotics administration, and continuous irrigation and debridement were common suggestion among the authors; however, the key measure undertaken or implied by most authors to avoid risk of recurrence was removal or replacement of implants for late-onset SSI.

Device-Related Complications Associated with Magec Rod Usage for Distraction-Based Correction of Scoliosis.

INTRODUCTION: Recent literature identifies similar failure rates such as anchor pull-out and rod breakage, but a higher unplanned revision surgery with MAGEC rods than with traditional growth rods. Besides known failure modes such as rod fracture, infection, etc., failure to noninvasively distract the rods was cited as the main cause of such unplanned surgeries. The source of these data ranges from multicenter cohort studies to singular case series. These studies included explanted implants that had undergone failure in distraction mechanism, rod fracture, or infection, or had reached their maximum length. Nevertheless, in addition to identifying the overall mode of failure, it is equally important to identify the large-scale incidence of exclusive failures in comparison with standard instrumentation failure modes in spine surgery. METHODS: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) databases were searched for reports on MAGEC rods, and on standard instrumentation used for spinal fusion. The adverse events were recorded, tabulated, and analyzed. RESULTS: A search of the US FDA MAUDE database yielded reports of 163 device-related adverse events. These included distraction mechanism failure (n=129), rod fracture (n=24), and minor voluntary reports of infection and tissue discoloration (n=10). For standard instrumentation usage in spine surgery, pedicle screw breakage post surgery (n=336), set screw damage during surgery (n=257), rod breakage post surgery (n=175), interbody cage breakage during surgery (n=118), and pedicle screw breakage during surgery (n=75) were identified as the top 5 failure modes. CONCLUSIONS: The study identified the distraction mechanism failure as the most common and growing complication associated with MAGEC rod usage in children with scoliosis, leading to unplanned invasive revision surgeries.