Finite element analysis comparing a PEEK posterior fixation device versus pedicle screws for lumbar fusion.

BACKGROUND: Pedicle screw loosening and breakage are common causes of revision surgery after lumbar fusion. Thus, there remains a continued need for supplemental fixation options that offer immediate stability without the associated failure modes. This finite element analysis compared the biomechanical properties of a novel cortico-pedicular posterior fixation (CPPF) device with those of a conventional pedicle screw system (PSS). METHODS: The CPPF device is a polyetheretherketone strap providing circumferential cortical fixation for lumbar fusion procedures via an arcuate tunnel. Using a validated finite element model, we compared the stability and load transfer characteristics of CPPF to intact conditions under a 415 N follower load and PSS conditions under a 222 N preload. Depending on the instrumented levels, two different interbody devices were used: a lateral lumbar interbody device at L4-5 or an anterior lumbar interbody device at L5-S1. Primary outcomes included range of motion of the functional spinal units and anterior load transfer, defined as the total load through the disk and interbody device after functional motion and follower load application. RESULTS: Across all combinations of interbody devices and lumbar levels evaluated, CPPF consistently demonstrated significant reductions in flexion (ranging from 90 to 98%), extension (ranging from 88 to 94%), lateral bending (ranging from 75 to 80%), and torsion (ranging from 77 to 86%) compared to the intact spine. Stability provided by the CPPF device was comparable to PSS in all simulations (range of motion within 0.5 degrees for flexion-extension, 0.6 degrees for lateral bending, and 0.5 degrees for torsion). The total anterior load transfer was higher with CPPF versus PSS, with differences across all tested conditions ranging from 128 to 258 N during flexion, 89-323 N during extension, 135-377 N during lateral bending, 95-258 N during torsion, and 82-250 N during standing. CONCLUSION: Under the modeled conditions, cortico-pedicular fixation for supplementing anterior or lateral interbody devices between L4 and S1 resulted in comparable stability based on range of motion measures and less anterior column stress shielding based on total anterior load transfer measures compared to PSS. Clinical studies are needed to confirm these finite element analysis findings.

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.

Distraction forces on the spine in early-onset scoliosis: A systematic review and meta-analysis of clinical and biomechanical literature.

Distraction-based growing rods are frequently used to treat Early-Onset Scoliosis. These use intermittent spinal distractions to maintain correction and allow for growth. It is unknown how much spinal distraction can be applied safely. We performed a systematic review and meta-analysis of clinical and biomechanical literature to identify such safety limits for the pediatric spine. This systematic review and meta-analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Three systematic searches were performed including in-vivo, ex-vivo and in-silico literature. Study quality was assessed in all studies and data including patient- or specimen characteristics, distraction magnitude and spinal failure location and ultimate force at failure were collected. Twelve studies were included, 6 in-vivo, 4 ex-vivo and 2 in-silico studies. Mean in-vivo distraction forces ranged between 242 and 621 N with maxima of 422-981 N, without structural failures when using pedicle screw constructs. In the ex-vivo studies (only cervical spines), segment C0-C2 was strongest, with decreasing strength in more distal segments. Meta-regression analysis demonstrated that ultimate force at birth is 300-350 N, which increases approximately 100 N each year until adulthood. Ex-vivo and in-silico studies showed that yielding occurs at 70-90% of ultimate force, failure starts at the junction between endplate and intervertebral disc, after which the posterior- and anterior long ligament rupture. While data on safety of distraction forces is limited, this systematic review and meta-analysis may aid in the development of guidelines on spinal distraction and may benefit the development and optimization of contemporary and future distraction-based technologies.

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.

Updates on Evidence-Based Practices to Reduce Preoperative and Intraoperative Contamination of Implants in Spine Surgery: A Narrative Review.

The current communication seeks to provide an updated narrative review on latest methods of reducing implant contaminations used during spine surgery. Recent literature review has shown that both preoperative reprocessing and intraoperative handling of implants seem to contaminate implants. In brief, during preoperative phase, the implants undergo repeated bulk cleaning with dirty instruments from the OR, leading to residue buildup at the interfaces and possibly on the surfaces too. This, due to its concealed nature, remains unnoticed by the SPD (sterile processing department) or other hospital staff. Nevertheless, these can be avoided by using individually prepackaged presterilized implants. In the intraoperative phase, the implants (in the sterile field) are directly touched by the scrub tech with soiled (assisting the surgeon dispose the tissues from the instruments in use) gloves for loading onto an insertion device. It is then kept exposed on the working table (either separately or next to the used instruments as the pedicles hole are being prepared). Latest investigation has shown that by the time it is implanted in the patient, it can harbor up to 10e7 bacterial colony-forming units. The same implants were devoid of such colony-forming units, when sheathed by an impermeable sterile sheath around the sterile implant.

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.

Active Apex Correction With Guided Growth Technique for Controlling Spinal Deformity in Growing Children: A Modified SHILLA Technique.

STUDY DESIGN: A retrospective study. OBJECTIVE: To determine if active remodulation in the apex of the curve is possible in scoliosis and kyphoscoliosis patients, using a modified SHILLA; active apex correction (APC) technique for guided growth. METHOD: Twenty patients with either scoliosis or kyphoscoliosis underwent a modified SHILLA approach, where instead of apical fusion, APC was applied. In this modified technique, the most wedged vertebra was selected followed by insertion of pedicle screws in the convex side of the vertebrae above and below the wedged one. The convex and concave heights of the wedged and control vertebrae were recorded at the time of the surgery and at follow-up duration, both using computed tomography. RESULTS: The wedged vertebra demonstrated in average a 17% (P = .00014) increase in the proportion of concave to convex heights ratio, whereas the control vertebra did not show any relative change in the wedged vertebra heights at the follow-ups. CONCLUSION: APC, instead of apical fusion in SHILLA remodulates the apex vertebra, which may in turn help mitigate loss of correction on long term due to crankshafting and adding-on.

A Multicenter Trial Demonstrating Presence or Absence of Bacterial Contamination at the Screw-Bone Interface Owing to Absence or Presence of Pedicle Screw Guard, Respectively, During Spinal Fusion.

STUDY DESIGN: A prospective multicenter study. OBJECTIVE: The objective of this study was to assess bacterial contamination in current practices of pedicle screw handling and comparing it to a novel method of using an intraoperative, sterile implant guard for screws. SUMMARY OF BACKGROUND DATA: Postoperative infections occur at the higher end of 2%-13%, as cited in the literature, and are underestimated due to various reasons in such publications. Despite concerns associated with vancomycin application immediately before closure, it is theoretically impossible to irrigate the screw-bone interface postimplantation. Consequently, any contamination of pedicle screw before implantation is permanent, and has the potential to cause deep-bone infection, or hardware loosening due to encapsulation of biofilm between the bone and the screw. Therefore, continued vigilance and effective preventive measures should be undertaken if available. MATERIALS AND METHODS: Two groups of presterile individually-packaged pedicle screws, one incased in a sterile, protective guard (group 1: G) and the other without such a guard (group 2: NG), 31 samples in each group were distributed over 28 spinal fusion surgeries at 5 independent hospitals groups. Each were loaded onto the insertion device by the scrub tech and left on the sterile table. Twenty minutes later, the lead surgeon who had just finished preparing the surgical site, handles the pedicle screw, to check the fit with the insertion device. Then, instead of implantation, it was transferred to a sterile container using fresh sterile gloves for bacterial analysis. RESULTS: The standard unguarded pedicle screws presented bioburden in the range of 10 to 10 colonies forming units per screw, whereas the guarded pedicle screws showed no bioburden. CONCLUSION: Standard, current, handling of pedicle screws leads to bacterial contamination, which can be avoided if the screws are sterilely prepackaged with an intraoperative guard (preinstalled).

Active Apex Correction (Modified SHILLA Technique) Versus Distraction-Based Growth Rod Fixation: What Do the Correction Parameters Say?

INTRODUCTION: SHILLA and growth rods are two main surgical correction techniques for patients with early-onset scoliosis. There have been some comparative studies between the two techniques, where a comparison was made between deformity identifying characteristics such as Cobb angle, apical vertebral translation, coronal balance, spinal length gain, etc. However, the SHILLA procedure experiences loss of correction or the reappearance of deformity through crankshafting or adding-on (e.g., distal migration). The current study identifies a solution with a modified approach to SHILLA (which could help in dynamically remodulating the apex of the deformity and mitigating loss of correction) and presents comparative correction data against the long-established traditional growth rod system. METHODS: The active apex correction (APC) group consisted of 20 patients and the growth rod group consisted of 26 patients, both with the same inclusion and exclusion criteria. The APC surgical procedure involved a modified SHILLA technique, that is, insertion of pedicle screws in the convex side of the vertebrae above and below the wedged one for compression and absence of apical fusion. RESULTS: There were no statistical differences between the various spinal parameters (namely, Cobb angle, apical vertebral translation, sagittal balance, and spinal length gain) of the two groups. However, significant differences existed for coronal balance, which in part may have been due to differences in its pre-op value between the two groups. CONCLUSIONS: APC and the traditional growth rod system showed similar deformity correction parameters at current follow-ups; however, the latter requires multiple surgeries to regularly distract the spine.

Spinal Balance/Alignment - Clinical Relevance and Biomechanics.

In the normal spine due to its curvature in various regions, C7 plumb line (C7PL) passes through the sacrum so that the head is centered over the pelvis-ball and socket hip joints and ankle joints. This configuration leads to the least muscular activities to maintain the spinal balance. For any reason like deformity, scoliosis, kyphosis, trauma, and/or surgery this optimal configuration gets disturbed requiring higher muscular activity to maintain the posture and balance. Several parameters like the thoracic kyphosis (TK), lumbar lordosis (LL), pelvic incidence (PI), sacral slope (SS), Hip- and leg position influence the sagittal balance and thus the optimal configuration of spinal alignment. Global sagittal imbalance is energy consuming and often painful compensatory mechanisms are developed, that in turn negatively influence the quality of life. This review looks at the clinical aspects of spinal imbalance, and the biomechanics of spinal balance as dictated by the deformities- ankylosing spondylitis, scoliosis and kyphosis; surgical corrections- pedicle subtraction osteotomies and long segment stabilizations and consequent postural complications like the proximal and distal junctional kyphosis. This review suggests several potential research topics as well.

Harboring Contaminants in Repeatedly Reprocessed Pedicle Screws.

STUDY DESIGN: It consisted of evaluation of the pedicle screws for presence of residual nonmicrobial contaminants and tabulation of the minimum steps and time required for reprocessing implants as per guidelines and its comparison with actual practice. OBJECTIVE: An evaluation of the nonmicrobial contaminants prevalent on the pedicle screws used for spine surgery and the underlying practice cause behind the source. METHODS: The first component consisted of a random selection of 6 pedicle screws and its assessment using optical microscopy, scanning electron microscopy with energy dispersive spectroscopy, and Fourier transform infrared spectroscopy. The second component consisted of review of implant reprocessing guidelines and its applicability. RESULTS: Three types of contaminants were identified: corrosion, saccharide of unknown origin, and soap residue mixed with and were mostly present at the interfaces with low permeability. In addition, manufacturer's guideline recommends 19 hours of reprocessing, whereas the real-time observation revealed a turnaround time of 1 hour 17 minutes. CONCLUSION: Repeatedly reprocessed pedicle screws host corrosion, carbohydrate, fat, and soap, which could be a cause of surgical site infection and inflammatory responses postsurgery. The cause behind it is the impracticality of repeated cleaning and inspection of such devices.

Efficacy of Intraoperative Implant Prophylaxis in Reducing Intraoperative Microbial Contamination.

STUDY DESIGN: A prospective single-center study. OBJECTIVES: Assess to what degree contamination of pedicle screws occur in standard intraoperative practice and if use of an impermeable guard could mitigate or reduce such an occurrence. METHODS: Two groups of sterile prepackaged pedicle screws, one with an intraoperative guard (group 1) and the other without such a guard (group 2), each consisting of 5 samples distributed over 3 time points, were loaded onto the insertion device by the scrub tech and left on the sterile table. Approximately 20 minutes later, the lead surgeon who had just finished preparing the surgical site touches the pedicle screw. Then instead of implantation it was transferred to a sterile container using fresh clean gloves for bacterial and gene analysis. Guarded screw implies that even after unwrapping from the package, the screw carries an impermeable barrier along its entire length, which is only removed seconds prior to implantation. RESULTS: The standard unguarded pedicle screws presented bioburden in the range of 105 to 107 (colony forming units/implant) with bacterial genus mostly consisting of Staphylococcus and Micrococcus, the 2 most common genera found in surgical site infection reports. The common species among them were Staphylococcus epidermis, Staphylococcus aureus, Micrococcus luteus, and Staphylococcus pettenkoferi, whereas the guarded pedicle screws showed no bioburden. CONCLUSIONS: Shielding the pedicle screws intraoperatively using a guard provides a superior level of asepsis than currently practiced. All unshielded pedicles screws were carrying bioburden of virulent bacterial species, which provides an opportunity for the development of postoperative infections.

Quantitative Characteristics of Consecutive Lengthening Episodes in Early-onset Scoliosis (EOS) Patients With Dual Growth Rods.

STUDY DESIGN: A prospective single-center study. OBJECTIVE: The aim of this study was to record the characteristic forces and lengths observed during distraction episodes in early-onset scoliosis (EOS), and analyze their interdependencies on the key variability among the patients. SUMMARY OF BACKGROUND DATA: The goal of the growing-rod technique is to achieve deformity correction alongside maintaining growth of the spine. The deformity correction is achieved during the initial surgery, but follow-up distraction episodes are necessary to maintain the growth. The key variables, under the control of a surgeon, that affect the growth are the applied distraction forces and the distraction lengths. Since the advent of dual growth rod technique, there have been many studies exploring the relationship between these and the actual growth. However, there is sparse evidence on the actual magnitude of distraction forces, and none on its association with patient's parameters such as sex, age, and deformity. METHODS: In a consecutive series of 47 patients implanted with dual growth rods, the distraction forces (in N) and the lengths (in mm) achieved during each distraction episode and compared against the episode-specific demographics. The values obtained from each side, that is, concave and convex sides, were averaged to calculate the mean. Statistical analysis was performed using t-distribution because for each normalized time points (distraction episode). RESULTS: In cumulative, the distraction force increased by an amount of 268%, with 120% increase in the early stages (distractions episodes 1-6) and 68% increase in the later stages (distractions episodes 6-11), whereas the cumulative decrease in the length over 11 distractions episodes was 47%, with 34% and 20% in the early and later stages, respectively. The study does not identify any significant trend with respect to sex, age, and deformity. CONCLUSION: The distraction force and the length increased and decreased respectively with every consecutive distraction episode, with no correlation to sex, age, extent of deformity, or the extent of correction. LEVEL OF EVIDENCE: 5.

Implant Prophylaxis: The Next Best Practice Toward Asepsis in Spine Surgery.

STUDY DESIGN: A literature review. OBJECTIVES: An evaluation of the contaminants prevalent on implants used for surgery and the aseptic methods being employed against them. METHODS: PubMed was searched for articles published between 2000 and 2017 for studies evaluating the contaminants present on spine implants, and associated pre- and intraoperative implant processing and handling methodology suggested to avoid them. Systematic reviews, observational studies, bench-top studies, and expert opinions were included. RESULTS: Eleven studies were identified whose major focus was the asepsis of implants to reduce the incidence of surgical site infection incidences during surgery. These studies measured the colony forming units of bacteria on sterilized implants and/or gloves from the surgeon, scrub nurse, and assistants, as well as reductions of surgical site infection rates in spine surgery due to changes in implant handling techniques. Additionally, the search included assessments of endotoxins and carbohydrates present on reprocessed implants. The suggested changes to surgical practice based on these studies included handling implants with only fresh gloves, keeping implants covered until the immediate time of use, reducing operating room traffic, avoiding reprocessing of implants (ie, providing terminally sterilized implants), and avoiding touching the implants altogether. CONCLUSIONS: Both reprocessing (preoperative) and handling (intraoperative) of implants seem to lead to contamination of sterilized implants. Using a terminally sterilized device may mitigate reprocessing (preoperative implant prophylaxis), whereas the use of fresh gloves for handling each implant and/or a permanent shielding technique (intraoperative implant prophylaxis) could potentially avoid recontamination at the theatre.

A Paradigm Shift Toward Terminally Sterilized Devices.

Given the complexity of the sterilization process, and the risk involved in absence of strict adherence to the protocol described by the medical device manufacturers, terminally sterilized devices are emerging and being promoted in the field of medical practices. The characteristics associated with conventional reprocessing are demanding logistics, costs of delay, operations and adverse events, and unacceptable liability. Demanding logistics were a result of decoupled staff between the operating room and sterilize processing department, understaffed and high-volume processing with an additional burden due to inventory management and inefficient training. Other costs arose from upkeep, delay in operating room, and surgical-site infections. Liability arose from the repeatedly use of an unquantifiable process thus adding uncertainties, limited shelf life of the reprocessed implants, contingency of flash sterilization and introduction of newer technology with higher demand on cleaning performances. In contrast, terminally sterilized single-use devices do not carry any of the aforementioned-characteristics, deeming it to be the simplest solution to the current conundrum. This review serves to provide an evaluation of logistics, costs, and potential adverse effects, both directly and indirectly, associated with current practices in the sterile processing department, and also describes as to how the use of terminally sterilized devices can help circumvent those.

Patient-specific Distraction Regimen to Avoid Growth-rod Failure.

STUDY DESIGN: A finite element study to establish the relationship between patient's curve flexibility (determined using curve correction under gravity) in juvenile idiopathic scoliosis and the required distraction frequency to avoid growth rod fracture, as a function of time. OBJECTIVE: To perform a parametric analysis using a juvenile scoliotic spine model (single mid-thoracic curve with the apex at the eighth thoracic vertebra) and establish the relationship between curve flexibility (determined using curve correction under gravity) and the distraction interval that allows a higher factor of safety for the growth rods. SUMMARY OF BACKGROUND DATA: Previous studies have shown that frequent distraction with smaller magnitude of distractions are less likely to result in rod failure. However there has not been any methodology or a chart provided to apply this knowledge on to the individual patients that undergo the treatment. This study aims to fill in that gap. METHOD: The parametric study was performed by varying the material properties of the disc, hence altering the axial stiffness of the scoliotic spine model. The stresses on the rod were found to increase with increased axial stiffness of the spine, and this resulted in the increase of required optimal frequency to achieve a factor of safety of two for growth rods. RESULTS: A relationship between the percentage correction in Cobb's angle due to gravity alone, and the required distraction interval for limiting the maximum von Mises stress to 255 MPa on the growth rods was established. The distraction interval required to limit the stresses to the selected nominal value reduces with increase in stiffness of the spine. Furthermore, the appropriate distraction interval reduces for each model as the spine becomes stiffer with time (autofusion). This points to the fact the optimal distraction frequency is a time-dependent variable that must be achieved to keep the maximum von Mises stress under the specified factor of safety. CONCLUSION: The current study demonstrates the possibility of translating fundamental information from finite element modeling to the clinical arena, for mitigating the occurrence of growth rod fracture, that is, establishing a relationship between optimal distraction interval and curve flexibility (determined using curve correction under gravity). LEVEL OF EVIDENCE: N/A.