Surgical growth guidance with non-fused anchoring segments in early-onset scoliosis.

PURPOSE: Surgical treatment of early-onset scoliosis (EOS) requires a balance between maintained curve correction and the capacity for spinal and thoracic growth. Spinal fusion creates irreversible conditions that prevent the implementation of further treatment methods. Our hypothesis was that non-fused anchors in growth guidance show a comparable outcome as the technique described in the literature, which involves spondylodesis of the anchoring segments. METHODS: This retrospective study analysed 148 surgeries in 22 EOS patients (11 female, 11 male) over a 15-year period. Patients underwent surgery with non-fused anchors and growth guidance techniques. Scoliosis, kyphosis, growth and anchoring segments were measured. For the latter, a new measuring technique was developed. Complications were recorded and classified. RESULTS: The mean Cobb angle reduced from 73.5 ± 24.4° to 28.4 ± 16.2° (60.2 ± 22.9%, p < 0.001) at the last follow-up. Spinal growth T1-S1 and T1-T12 were 41.1 ± 23.3 mm and 24.9 ± 16.6 mm (p < 0.001), respectively. Growth at the cranial and caudal anchoring segment was 1.5 mm/segment/year and 1.9 mm/segment/year, respectively. A total of 63 complications were documented in 20 patients, with 40 requiring unplanned revision surgery. Definitive spondylodesis was performed in three patients. CONCLUSION: Patients demonstrated a significant spinal growth including the anchoring segments. A comparable correction in Cobb angle and the type of complications was noted, although the rate of device-related complications was higher. No permanent impairment was reported. The rate of device-related complications is acceptable and outweighed by the significant degree of growth preservation and more flexible and individualised treatment strategy for patients with EOS. These slides can be retrieved under Electronic Supplementary Material.

Changes in sagittal balance and pre-existing junctional angle influence development of proximal junctional kyphosis in growth guidance systems for early-onset scoliosis.

PURPOSE: Proximal junctional kyphosis (PJK) has been reported to occur at a rate of about 30% in traditional growing rods (GR) and magnetically controlled growing rods (MCGR). Growth guidance systems (GGS) have non-rigid, gliding fixation along rods, which may mitigate PJK. There have been no studies done in shilla around PJK, hence this study aimed to assess the occurrence, risk factors, and timeline of PJK. METHODS: A prospective, multicenter database was queried for EOS patients who underwent surgery utilizing GGS. INCLUSION CRITERIA: < 10 years at index surgery and > 2 year follow-up. RESULTS: Sixty-five patients (thirty-six female) met inclusion criteria. Mean age at index surgery was 6.2 y/o (2-9); mean follow-up was 66 m. Most common etiologies were syndromic (n = 23). Mean thoracic kyphosis at pre-op was 41.8°, post-op was 35.5°, and final was 42.2°. Mean PJA at pre-op was 6.15°, post-op 1 was 4.2°, and final was 15.6°. Incidence of PJK at post-op was 35% and final was 43%. Pre-op sagittal balance and change in sagittal balance from pre-op to post-op were associated with post-op PJK (p = 0.05, 0.02). Change in spinal height from pre-op to post-op was associated with PJK at final (p = 0.04). Interestingly, increased PJA at pre-op was significantly associated with decreased PJK at post-op and final (p = 0.01, 0.03). CONCLUSION: PJK was identified in 43% of patients post-operatively after GGS for EOS. Pre-op PJA was negatively correlated with an increased incidence of PJK. Changes in sagittal balance, in either direction, was the strongest predictor for development of PJK post-operatively.

A Novel growth guidance system for early onset scoliosis: a preliminary in vitro study.

PURPOSE: The purpose of the study was to describe a novel growth guidance system, which can avoid metal debris and reduce the sliding friction forces, and test the durability and glidability of the system by in vitro test. METHOD: Two major modifications were made to the traditional Shilla system, including the use of ultra-high molecular weight polyethylene (UHMWPE) gaskets to avoid direct contact between the screw and rod, and polishing the surface of the sliding part of the rod. We tested the durability of the system by a fatigue test, which the samples were test on the MTS system for a 10 million cycle of a constant displacement. Pre and post-testing involved weighing the UHMWPE gaskets and observing the wear conditions. The sliding ability were measured by a sliding displacement test. The maximum sliding displacement of the system was measured after a 300 cycles of dynamic compressive loads in a sinusoidal waveform. RESULTS: After the fatigue test, all the UHMWPE gaskets samples showed some of the fretting on the edge of the inner sides, but its still isolated and avoided the friction between the screws and rods. There was no production of metallic fretting around the sliding screws and rods. The average wear mass of the UHMWPE gaskets was 0.002 ± 0.001 g, less than 1.7% of the original mass. In the sliding test, the novel growth guidance system demonstrated the best sliding ability, with an average maximum sliding distance(AMSD) of 35.75 ± 5.73 mm, significantly better than the group of the traditional Shilla technique(AMSD 3.65 ± 0.46 mm, P < 0.0001). CONCLUSION: In conclusion, we modified the Shilla technique and designed a novel growth guidance system by changing the friction interface of sliding screw and rod, which may significantly reduce the metallic debris and promote spine growth. The fatigue test and sliding dislocation test demonstrated the better durability and glidability of the system. An in vivo animal experiment should be performed to further verify the system.

Spinal height for growth guidance treatment in early onset idiopathic scoliosis: analysis through final surgical treatment.

BACKGROUND: The growth guidance (GG) method for treatment of early onset scoliosis has as its primary goal the restoration of apical spinal alignment, facilitating normal spinal growth to achieve a suitable adult thoracic height. PURPOSE: To evaluate whether GG surgical treatment achieves comparable thoracic and spinal height to distraction-based treatment (DBT) in idiopathic early onset scoliosis (I-EOS) patients. We hypothesized that GG would prove superior to DBT at the time of definitive fusion surgery. METHODS: All I-EOS patients who underwent GG at a single center were reviewed. T1-L1 and T1-S1 heights were measured using the traditional coronal method as well as the Halifax sagittal spinal length (SSL) technique. The same measurements were obtained from a comparable control group obtained from a multi-center pediatric early onset scoliosis database who underwent treatment with traditional growing rods (TGR) or magnetically controlled growing rods (MCGR). RESULTS: Of the I-EOS patients who underwent GG 2004-2019, 15 patients underwent final fusion after GG completion, with a mean 5.5 years of GG treatment prior to fusion (range 2.0-11.4 years). Mean age at GG implantation was 8.4 years (range 2.0-11.7 years); 7 were male and 8 female. GG patients experienced a mean coronal thoracic height increase of 6.2 cm during treatment through final fusion, and a mean coronal spinal height increase of 8.8 cm. At the time of final fusion, GG patients achieved greater significant mean increases than DBT patients by 2.9 cm in coronal thoracic height (p = 0.0023), 4.5 cm in coronal spinal height (p = 0.001), and 4.0 cm in SSL spinal height (p = 0.01). No GG patient concluded treatment with a thoracic height less than 18 cm in either coronal or sagittal plane. CONCLUSIONS: Not only did 100% of GG patients reach minimum thoracic height of 18 cm at time of final fusion, but GG also proved to be superior to distraction-based constructs in a comparison cohort on 3 of 4 spinal elongation measures. LEVEL OF EVIDENCE: 3.

Diagnostic and therapeutic strategies in early onset scoliosis: A current concept review.

Substantial advances in the treatment of early onset scoliosis (EOS) over the past two to three decades have resulted in significant improvements in health-related quality of life of affected children. In addition to classifications that address the marked heterogeneity of this patient population, increasing understanding of the natural history of the disease, and new implants and treatment techniques have resulted in innovations unlike any other area of pediatric orthopedics. The growing understanding of the interaction between spinal and thoracic growth, as well as dependent lung maturation, has had a lasting impact on the treatment strategy of this potentially life-threatening disease. The previous treatment approach with early corrective fusion gave way to a growth-friendly concept. Despite the steady development of new growth-friendly surgical treatment options, whose efficacy still needs to be validated, as well as a revival of conservative growth control with serial casts and/or braces, the psychosocial burden of the long lasting and complication-prone treatments remains high. As a consequence, EOS still represents one of the greatest pediatric orthopedic challenges.

Implant-Related Complications Do Not Interfere with Corrections with the Shilla Technique in Early Onset Scoliosis: Preliminary Results.

Growth-preservation techniques are utilized in early onset scoliosis (EOS) cases requiring surgical intervention. The Shilla technique corrects the deformity by reducing additional surgeries with its growth-guidance effect. As with other techniques, various problems can be encountered following the administration of the Shilla technique. The aim of this study was to examine the effect of complications encountered with the Shilla treatment on correction and growth. Sixteen patients with a follow-up period of at least one year after receiving Shilla growth guidance for EOS were included in this retrospective study. No complications occurred, and no unplanned surgery was required in 50% of the cases. Of the remaining eight patients with postoperative implant-related complications (50%), six (37.5%) required unplanned surgery; this consequently caused implant failure in the proximal region in five cases (31.25%) and deep tissue infection around the implant in one case (6.25%). Deformity correction, spine length, and quality-of-life scores significantly improved in EOS through Shilla growth guidance. In terms of spinal growth and deformity correction, there were no significant differences between patients with implant-related problems and individuals without occurrences. Although implant-related problems were detected in our dataset and corresponding unexpected surgeries were necessary, these complications had no significant unfavorable influence on correction and spine growth.

Factors for Prolonged Pain and Restriction of Movement Following Hemiepiphysiodesis Plating for the Correction of Lower Limb Malalignment in the Frontal Plane: An Explorative Analysis.

The correction of valgus leg malalignment in children using implant-mediated growth guidance is widely used and effective. Despite the minimal invasive character of the procedure, a relevant number of patients sustain prolonged pain and limited mobility after temporary hemiepiphysiodesis. Our aim was to investigate implant-associated risk factors (such as implant position and screw angulation), surgical- or anesthesia-related risk factors (such as type of anesthesia, use, and duration), and pressure of tourniquet or duration of surgery for these complications. Thirty-four skeletally immature patients with idiopathic valgus deformities undergoing hemiepiphysiodesis plating from October 2018-July 2022 were enrolled in this retrospective study. Participants were divided into groups with and without prolonged complications (persistent pain, limited mobility of the operated knee between five weeks and six months) after surgery. Twenty-two patients (65%) had no notable complications, while twelve patients (35%) had prolonged complications. Both groups differed significantly in plate position relative to physis (p = 0.049). In addition, both groups showed significant differences in the distribution of implant location (p = 0.016). Group 1 had a shorter duration of surgery than group 2 (32 min vs. 38 min, p = 0.032) and a lower tourniquet pressure (250 mmHg vs. 270 mmHg, p = 0.019). In conclusion, simultaneous plate implantation at the femur and tibia and metaphyseal plate positioning resulted in prolonged pain and a delay of function. In addition, the amplitude of tourniquet pressure or duration of surgery could play a factor.

Light-to-Heat Converting ECM-Mimetic Nanofiber Scaffolds for Neuronal Differentiation and Neurite Outgrowth Guidance.

The topological cues of fibrous scaffolds (in particular extracellular matrix (ECM)-mimetic nanofibers) have already proven to be a powerful tool for influencing neuronal morphology and behavior. Remote photothermal optical treatment provides additional opportunities for neuronal activity regulation. A combination of these approaches can provide "smart" 3D scaffolds for efficient axon guidance and neurite growth. In this study we propose two alternative approaches for obtaining biocompatible photothermal scaffolds: surface coating of nylon nanofibers with light-to-heat converting nanoparticles and nanoparticle incorporation inside the fibers. We have determined photoconversion efficiency of fibrous nanomaterials under near infrared (NIR) irradiation, as well as biocompatible photothermal treatment parameters. We also measured photo-induced intracellular heating upon contact of cells with a plasmonic surface. In the absence of NIR stimulation, our fibrous scaffolds with a fiber diameter of 100 nm induced an increase in the proportion of ß3-tubulin positive cells, while thermal stimulation of neuroblastoma cells on nanoparticles-decorated scaffolds enhanced neurite outgrowth and promoted neuronal maturation. We demonstrate that contact guidance decorated fibers can stimulate directional growth of processes of differentiated neural cells. We studied the impact of nanoparticles on the surface of ECM-mimetic scaffolds on neurite elongation and axonal branching of rat hippocampal neurons, both as topographic cues and as local heat sources. We show that decorating the surface of nanofibers with nanoparticles does not affect the orientation of neurites, but leads to strong branching, an increase in the number of neurites per cell, and neurite elongation, which is independent of NIR stimulation. The effect of photothermal stimulation is most pronounced when cultivating neurons on nanofibers with incorporated nanoparticles, as compared to nanoparticle-coated fibers. The resulting light-to-heat converting 3D materials can be used as tools for controlled photothermal neuromodulation and as "smart" materials for reconstructive neurosurgery.

ECM-Mimetic Nylon Nanofiber Scaffolds for Neurite Growth Guidance.

Numerous nanostructured synthetic scaffolds mimicking the architecture of the natural extracellular matrix (ECM) have been described, but the polymeric nanofibers comprising the scaffold were substantially thicker than the natural collagen nanofibers of neural ECM. Here, we report neuron growth on electrospun scaffolds of nylon-4,6 fibers with an average diameter of 60 nm, which closely matches the diameter of collagen nanofibers of neural ECM, and compare their properties with the scaffolds of thicker 300 nm nanofibers. Previously unmodified nylon was not regarded as an independent nanostructured matrix for guided growth of neural cells; however, it is particularly useful for ultrathin nanofiber production. We demonstrate that, while both types of fibers stimulate directed growth of neuronal processes, ultrathin fibers are more efficient in promoting and accelerating neurite elongation. Both types of scaffolds also improved synaptogenesis and the formation of connections between hippocampal neurons; however, the mechanisms of interaction of neurites with the scaffolds were substantially different. While ultrathin fibers formed numerous weak immature ß1-integrin-positive focal contacts localized over the entire cell surface, scaffolds of submicron fibers formed ß1-integrin focal adhesions only on the cell soma. This indicates that the scaffold nanotopology can influence focal adhesion assembly involving various integrin subunits. The fabricated nanostructured scaffolds demonstrated high stability and resistance to biodegradation, as well as absence of toxic compound release after 1 month of incubation with live cells in vitro. Our results demonstrate the high potential of this novel type of nanofibers for clinical application as substrates facilitating regeneration of nervous tissue.

Spring distraction system for dynamic growth guidance of early onset scoliosis: two-year prospective follow-up of 24 patients.

BACKGROUND: Current surgical treatment options for early onset scoliosis (EOS), with distraction- or growth-guidance implants, show limited growth and high complication rates during follow-up. We developed a novel implant concept, which uses compressed helical springs positioned around the rods of a growth-guidance construct. This spring distraction system (SDS) provides continuous corrective force to stimulate spinal growth, can be easily contoured, and can be used with all standard spinal instrumentation systems. PURPOSE: To assess curve correction and -maintenance, spinal growth, complication rate, and health-related quality of life following SDS treatment. STUDY DESIGN: Prospective cohort study. PATIENT SAMPLE: All skeletally immature EOS patients with an indication for growth-friendly surgery and without bone- or soft tissue weakness were eligible to receive SDS. For this study, all included patients with at least 2-year follow-up were analyzed. OUTCOME MEASURES: Coronal Cobb angle, sagittal parameters, T1-T12, T1-S1, and instrumented (ie, bridged segment) spinal height and freehand length, complications and re-operations, and the 24-Item Early Onset Scoliosis Questionnaires (EOSQ-24) score. METHODS: All primary- and conversion patients (conversion from failed other systems) with SDS and ≥2 years follow-up were included. Radiographic parameters were compared preoperatively, postoperatively and at latest follow-up. Spinal length increase was expressed as mm/year. RESULTS: Twenty-four skeletally immature EOS patients (18 primary and 6 conversion cases) were included. There were five idiopathic, seven congenital, three syndromic, and nine neuromuscular EOS patients. Mean age at implantation was 9.1 years (primary: 8.4; conversion: 11.2). Major curve improved from 60.3° to 35.3°, and was maintained at 40.6° at latest follow-up. Mean spring length increase during follow-up was 10.4 mm/year. T1-S1 height increased 9.9mm/year and the instrumented segment height showed a mean increase of 0.7 mm/segment/year. EOSQ-24 scores dropped after surgery from 75.6 to 67.4 but recovered to 75.0 at latest follow-up. In total, 17 reoperations were performed. Ten reoperations were performed to treat 9 implant-related complications. In addition, 7 patients showed spinal growth that exceeded expected growth velocity; their springs were retensioned during a small reoperation. CONCLUSION: The 2-year follow-up results from this prospective cohort study indicate that the concept of spring distraction may be feasible as an alternative to current growing spine solutions. Curve correction and growth could be maintained satisfactory without the need for repetitive lengthening procedures. However, as in all growth-friendly implants, complications and reoperations could not be prevented, which emphasizes the need for further improvement.

Low-Intensity Pulsed Ultrasound Enhanced Neurite Guidance Growth through Netrin-1/DCC Signal Pathway in Primary Cultured Cortical Neurons of Rats.

Low-intensity pulsed ultrasound is found to be effective in axonal regeneration, while the role of ultrasound in axonal growth guidance is still unclear. This study was performed to explore the neuroprotective role of low-intensity pulsed ultrasound (US) both in vitro and in vivo. Primary cultured rat cortical neurons were subjected to 1.0 MHz ultrasound for 5 min every day at intensity of 0, 0.008, 0.12, and 0.21 W/cm2. Our results demonstrated that low-intensity pulsed ultrasound significantly increased neuronal cell viability and inhibited neuronal apoptosis in vitro as determined by fluorescein diacetate assay (FDA) and a TdT-mediated biotin-dUTP nicked-end labeling (TUNEL) assay. Moreover, low-intensity pulsed ultrasound at 0.12 W/cm2 significantly enhanced the axonal growth guidance by activation of netrin-1 and DCC (deleted in colorectal carcinoma) expression as determined by Western blots assay. More interestingly, we further found that low-intensity pulsed ultrasound treatment at 0.21 W/cm2 promoted the functional restoration of rat injured nerves in vivo, decreased hemorrhage, and reversed the injury process by activating positive netrin-1 expression as seen in the immunohistochemistry (IHC) assay. Thus, our study strongly demonstrated that low-intensity pulsed ultrasound activated netrin-1/DCC signaling and further mediated neurite outgrowth. It would be a new approach to nerve regeneration in the future.

The Use of Metal Sublaminar Wires in Modern Growth-Guidance Scoliosis Surgery: A Report of 4 Cases and Literature Review.

BACKGROUND: To avoid early fusion and allow residual growth of the spine in early onset scoliosis (EOS) treatment, growth-guided scoliosis surgery can be performed. Four patients with EOS are presented in which a growth-guidance instrumentation is used with sliding titanium (Ti) sublaminar cables. Residual growth of the spine can be preserved using metal sublaminar wiring; however, several drawbacks of this technique and type of material are illustrated. METHODS: Four patients with progressive neuromuscular scoliosis were treated with a posterior stabilization. A fusionless growth-guidance instrumentation was used consisting of a combination of lumbar pedicle screws and sliding Ti sublaminar cables along cobalt chrome rods. RESULTS: In 2 cases, the described growth-guidance technique provided sufficient stability and correction of the curvature with preservation of growth. In 2 patients, the instrumentation failed due to upper thoracic sublaminar wire breakage. The ongoing abrasion of the rod-wire interface caused severe metallosis. In these cases, a debridement and revision surgery was performed with partial fusion of the spine. CONCLUSIONS: Growth-guidance techniques with sliding metal sublaminar wires seem to be a valuable solution for the preservation of spinal growth in EOS surgery. High curvatures, however, have a higher chance of failure and demand for more corrective strength and support of the instrumentation. The use of metal sublaminar wires in a "sliding" instrumentation can lead to early breakage and metallosis. LEVEL OF EVIDENCE: 4, case series. CLINICAL RELEVANCE: Surgeons should be aware of possible complications associated with the use of metal laminar wires in spinal fusion and growth-guidance scoliosis surgery. The implementation of materials containing higher fatigue strength and lower friction properties (eg, UHMWPE wires) may avoid these potential complication risks.

Active Apex Correction: An overview of the modified SHILLA technique and its clinical efficacy.

OBJECTIVE: Provide current overview of Active Apex correction as a new technique for surgical management for Early Onset Scoliosis by dynamically remodulating the apex of the deformity and mitigate loss of correction and presents a comparative correction data against the long-established systems. METHOD: Summary of the surgical technique and review of the existing retrospective data on APC surgical technique and its comparison against other existing techniques. RESULTS: Retrospective clinical results showed the efficiency of the APC technique in active remodulation of the apex of the curve with lower incidence of implant related complications in comparison to SHILLA and Magnetically Controlled Growing Rods (MCGR). APC also showed similar results with traditional growing rods without the need for repeated distraction surgeries for 4 years. CONCLUSION: Active Apex Control is safe and viable option in surgical management for Early Onset Scoliosis patients even in areas with limited resources.

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.

Stainless steel wear debris of a scoliotic growth guidance system has little local and systemic effect in an animal model.

Options to treat early-onset scoliosis include guided-growth systems with sliding action between rods and pedicle screws. The wear was previously measured in an in vitro test, and in this in vivo rabbit model, we evaluated the local and systemic biological response to the stainless steel debris. Compared to the previous study, a relatively higher volume of representative wear particles with a median particle size of 0.84 µm were generated. Bolus dosages were injected into the epidural space at L4-L5 for a minimum of 36 rabbits across three treatment groups (negative control, 1.5 mg, and 4.0 mg) and two timepoints (12 and 24 weeks). Gross pathology evaluated distant organs and the injection site with a dorsal laminectomy to examine the epidural space and dosing site. Peri-implanted particle tissues were stained for immunohistochemical and quantitatively analyzed for IL-6 and TNF-α cytokines. Based on ISO 10993-6:2007 scoring, particles in the high-dose group were primarily non-irritant (12 weeks) with one slightly irritant. At 24 weeks, inflammatory cell infiltration was non-existent to minimal with all groups considered non-irritant at the injection site. Material characterization confirmed that particles detected in distant organs were stainless steel or contaminants. At 12 weeks, stainless steel groups demonstrated statistically increased amounts of cytokine levels compared to control but there was a statistical decrease for both at 24 weeks. These findings indicate that stainless steel wear debris, comparable to the expected usage from a simulated growth guidance system, had no discernible untoward biological effects locally and systemically in an animal model. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:1980-1990, 2018.

Temporary epiphysiodesis using the FlexTack™ implant (tension band) featuring a modified explantation technique.

OBJECTIVE: Presenting the implantation of the PediatrOS™ FlexTack™ (Merete, Berlin, Germany) for growth guidance and a modified explantation procedure to facilitate explantation and prevent bone and soft tissue damage. INDICATIONS: Implantation: Genua vara and valga, coxa vara, varus and valgus deviation of the ankle joint, the elbow joint and the wrist Modified Explantation: Removal of the implant after successful limb correction or dislocation of the implant. CONTRAINDICATIONS: Implantation: Closed growth plates, insufficient remaining growth potential, acute or chronic infection, insufficient osseous structures, severe muscular, nervous or vessel diseases endangering the respective limb Explantation: General inoperability of the patient. SURGICAL TECHNIQUE: Implantation: Localization of the growth plate. Insertion of K­wire parallel to joint line on the joint side. Setting of the implant. Insertion of second K­wire and insertion with the implantation instrument and hammer. Modified Explantation: Cutting of the implant bridging part. Both ends of the bridging part are bent vertically to prevent soft tissue damage. Dissection of both implant arms from the bone with the chisel. Extraction in 360° motion using tooth extraction pliers. POSTOPERATIVE MANAGEMENT: Implantation: Full weight bearing. X­ray controls every 3 months to control growth correction. Explantation: Full weight bearing. RESULTS: Complications such as breaking of the k­wires, breaking of the chisel or extraction of adhering bone tissue occurred in 14 of the 64 (21.9%) explanted FlexTack implants. Complication-free removal using the original instruments provided by the manufacturer was possible for five implants. The modified explantation procedure as described above was applied in 45 explanted implants (70.3%) with complete removal of the implant without further complications within the follow up period.

3D axon growth by exogenous electrical stimulus and soluble factors.

Axon growth and alignment are fundamental processes during nervous system development and neural regeneration after injury. The present study investigates the effects of exogenous stimulus of electrical signals and soluble factors on axon 3D growth, using a silk protein material-based 3D brain tissue model. Electrical stimulus was delivered via embedded gold wires positioned at the interface of the scaffold region and the center matrix gel-filled region, spanning the axon growth area. This setup delivered applied electrical field directly to growing axons, and the effects were compared to micro-needle assisted local delivery of soluble factors of extracellular (ECM) components and neurotrophins. Dissociated rat cortical neurons were exposed to an alternating field of 80 mV/mm at 0.5 Hz to 2 kHz or soluble factors for up to 4 days, and evaluated by of ß III-tubulin immunostaining, confocal imaging and 3D neurite tracing. 0.5-20 Hz were found to promote axon growth, with 2 Hz producing the biggest effect of ∼30% axon length increase compared to control cultures. Delivery of ECM components of laminin and fibronectin resulted significantly greater axon initial length increases compared to neurotrophic factors, such as BDNF, GDNF, NGF and NT3 (all at 1 µM). Though axon lengths under 2 Hz stimulation and LN or FN exposure were statistically similar, significant AC-induced axon alignment was found under all frequencies tested. The effects included perpendicular orientation of axons trespassing an electrode, large populations of aligned axon tracts in parallel to the field direction with a few perpendicularly aligned along the middle point of the EF. These findings are consistent with the hypothesis that an electrode in AC field could act as an alternating cathode that attracts the growing tip of the axon. These results demonstrate the use of alternating electric field stimulation to direct axon 3D length growth and orientation. Our study provides basis for further optimizing stimulation parameters, in conjunction of delivery of growth promoting soluble factors to direct axon growth in a brain mimetic 3D environment. This system provides a platform for studying the effects of exogenous signals on nervous system development and for testing neuromodulation approaches for neurological diseases.

Cost analysis of a growth guidance system compared with traditional and magnetically controlled growing rods for early-onset scoliosis: a US-based integrated health care delivery system perspective.

PURPOSE: Treating early-onset scoliosis (EOS) with traditional growing rods (TGR) is effective but requires periodic surgical lengthening, risking complications. Alternatives include magnetically controlled growing rods (MCGR) that lengthen noninvasively and the growth guidance system (GGS), which obviate the need for active, distractive lengthenings. Previous studies have reported promising clinical effectiveness for GGS; however the direct medical costs of GGS compared to TGR and MCGR have not yet been explored. METHODS: To estimate the cost of GGS compared with MCGR and TGR for EOS an economic model was developed from the perspective of a US integrated health care delivery system. Using dual-rod constructs, the model estimated the cumulative costs associated with initial implantation, rod lengthenings (TGR, MCGR), revisions due to device failure, surgical-site infections, device exchange, and final spinal fusion over a 6-year episode of care. Model parameters were from peer-reviewed, published literature. Medicare payments were used as a proxy for provider costs. Costs (2016 US$) were discounted 3% annually. RESULTS: Over a 6-year episode of care, GGS was associated with fewer invasive surgeries per patient than TGR (GGS: 3.4; TGR: 14.4) and lower cumulative costs than MCGR and TGR, saving $25,226 vs TGR. Sensitivity analyses showed that results were sensitive to changes in construct costs, rod breakage rates, months between lengthenings, and TGR lengthening setting of care. CONCLUSION: Within the model, GGS resulted in fewer invasive surgeries and deep surgical site infections than TGR, and lower cumulative costs per patient than both MCGR and TGR, over a 6-year episode of care. The analysis did not account for family disruption, pain, psychological distress, or compromised health-related quality of life associated with invasive TGR lengthenings, nor for potential patient anxiety surrounding the frequent MCGR lengthenings. Further analyses focusing strictly on current generation technologies should be considered for future research.

Radiographic Outcomes of Shilla Growth Guidance System and Traditional Growing Rods Through Definitive Treatment.

STUDY DESIGN: Retrospective review of a multicenter database. OBJECTIVES: To compare the radiographic outcomes of patients who had undergone the Shilla Growth Guidance System (SGGS) and traditional growing rod (GR) treatment for management of early-onset scoliosis (EOS) through definitive treatment. SUMMARY OF BACKGROUND DATA: The efficacy of surgical treatment of EOS can only be determined after definitive treatment has been completed. We wanted to review our experience with the SGGS and GR for management of EOS through definitive treatment. METHODS: Patients who had surgical treatment with SGGS or GR and had undergone definitive treatment were included. The patients were matched by age, preoperative curve magnitude, and diagnosis. The study population consisted of 36 patients (18 in each group) whose mean age at initial surgery was as follows: SGGS, 7.9 years; and GR, 7.7 years (not significant [NS]). Length of follow-up after initial surgery was 6.1 years for SGGS and 7.4 years for GR (NS). Definitive treatment was posterior spinal fusion (15 SGGS, 17 GR), implant removal (3 SGGS), or completion of lengthenings (1 GR). RESULTS: The preoperative curve was 61 degrees for SGGS and 65 degrees for GR (NS). After index surgery, the major curve decreased to 24 degrees (-37 degrees) for SGGS and 38 (-27 degrees) for GR (p < .05). At last follow-up, the major curve was 34 degrees (44%) for SGGS and 36 degrees (45%) for GR (NS). The initial T1-T12 length for SGGS was 188 mm and for GR, 181 mm; at last follow-up, SGGS was 234 mm (46 mm increase) and GR was 233 mm (52 mm increase) (NS). CONCLUSION: Our analysis shows the final radiographic outcomes (and changes) and complications (implant-related and infection) between the SGGS and GR groups were not statistically different. The main difference between the two groups was the threefold difference in overall surgeries.

Magnetic Force-Driven Graphene Patterns to Direct Synaptogenesis of Human Neuronal Cells.

Precise control of axonal growth and synaptic junction formation are incredibly important to repair and/or to mimic human neuronal network. Here, we report a graphene oxide (GO)-based hybrid patterns that were proven to be excellent for guiding axonal growth and its consequent synapse formation of human neural cells. Unlike the previous method that utilized micro-contacting printing technique to generate GO patterns, here, GO-encapsulated magnetic nanoparticles were first synthesized and utilized as core materials wherein the external magnetic force facilitated the transfer of GO film to the desired substrate. Owing to the intrinsic property of GO that provides stable cell attachment and growth for long-term culture, human neuronal cells could be effectively patterned on the biocompatible polymer substrates with different pattern sizes. By using magnetic force-driven GO hybrid patterns, we demonstrated that accumulation and expression level of Synaptophysin of neurons could be effectively controlled with varying sizes of each pattern. The synaptic network between each neuron could be precisely controlled and matched by guiding axonal direction. This work provides treatment and modeling of brain diseases and spinal cord injuries.