In vitro comparison of 1.5 mm vs. 2.0 mm screws for fixation in the sagittal split osteotomy

Purpose: Numerous "in vitro" investigations have been conducted to evaluate the role of screw size and pattern in determining optimal resistance to deformation, often these have been controversial. The aim of this study was to evaluate the effect of screw size and insertion technique on the stability of sagittal split osteotomies.Materials and methods: This study used twenty polyurethane replicas of human hemimandibles with a prefabricated sagittal split ramus osteotomy (SSRO). The hemimandibles were stabilized with 1.5 mm and 2.0 mm titanium screws inserted in an inverted L configuration. All specimens were tested to determine the strength and stability of the fixation.Results: In all cases there was failure of the synthetic bone before there was any evidence of screw failure. There were no significant differences in the load necessary to make the construct fail between the 1.5 or 2.0 mm screw sizes.Conclusion: There was no statistically significant difference between the strengths achieved with screws of 1.5 and 2.0 mm diameters for fixation of SSRO performed in synthetic mandibles. There was no fracture of the 1.5 mm or 2.0 mm diameter screws in any of the tests. 1.5 mm diameter screws in an inverted L pattern have as much stability and mechanical resistance as a 2.0 mm screw, may be safely used for this procedure. (C) 2010 European Association for Cranio-Maxillo-Facial Surgery.

Feasibility of Intralaminar, Lateral Mass, or Pedicle Axis Vertebra Screws in Children Under 10 Years of Age: A Tomographic Study

BACKGROUND: There are several techniques for screw insertion in upper cervical spine surgery, and the use of the 3.5-mm screw is usually the standard. However, there is no consensus regarding the feasibility of using these screws in the pediatric population. OBJECTIVE: To determine the measurement of the lamina angle, lamina and pedicle length and thickness, and lateral mass length of the topographic axial view of the axis vertebra of 2- to 10-year-old children to guide the use of surgical screws. METHODS: Seventy-five computed tomography scans from 24- to 120-month-old patients were studied. Measurements were taken in an axial view of C2 and correlated with 2 age groups and both sexes. Statistical analysis was performed with the Student t test. RESULTS: In the 24- to 48-month age group, only 5.5% of the lamina and 8.3% of the pedicles had thicknesses < 3.5 mm. In the 49- to 120-month age group, there were no lamina thickness values < 3.5 mm, and 1.2% of pedicle thicknesses were < 3.5 mm. Both age groups had no lamina and pedicle lengths < 12 mm and no lateral mass lengths > 12 mm. CONCLUSION: In the majority of cases, the use of 3.5-mm lamina and pedicle screws in children is feasible. A base value of 45 degrees for the spinolaminar angle can be adopted as a reference for insertion of screws in the C2 lamina. This information can be particularly useful for decision making during preoperative planning for C1-C2 or craniocervical arthrodesis in children.

Mechanical Performance of Cylindrical and Dual-Core Pedicle Screws After Repeated Insertion

Study Design. Ex vivo study of the mechanical performance of cylindrical and dual-core pedicle screws after insertion, removal, and reinsertion in the same hole. Objective. To evaluate the effect of repeated use of same screw hole on the insertion torque and the retentive strength of the cylindrical and dual-core screws. Summary of Background Data. Insertion and removal of pedicle screws is sometimes necessary during surgical procedure to assess the integrity of the pilot-hole wall. However, this maneuver may compromise the implant-holding capacity. Methods. Sixty thoracolombar vertebrae (T13-L5), harvested from 10 healthy calves, were used to insert 2 different designs of pedicle screws: cylindrical (5.0-mm outer diameter) and dual-core screws (5.2-mm outer diameter). Three experimental groups were created on the basis of the number of insertions of the screws and 2 subgroups were established according to the core pedicle screw design (dual-core and cylindrical). The insertion torque was measured during initial insertion, second insertion, and third insertion. Pullout screw tests were performed using a universal testing machine to evaluate the pullout strength after initial insertion, second insertion, and third insertion. Results. Significant reductions of 38% in mean insertion torque and 30% in mean pullout strength of dual-core screw were observed between the initial insertion and the third insertion. The cylindrical screw observed significant reductions of 52.5% in mean insertion torque and 42.3% in mean pullout strength between the initial insertion and the third insertion. A reduction of mean insertion torque and pullout strength between the first insertion and the second insertion but without significance was also observed for both types of screws. Conclusion. Insertions and reinsertion of either cylindrical or dual-core pedicle screws have compromised insertion torque and pullout strength of the implants as measured by mechanical tests.

Correlation of Pullout Force of Kirschner (K-) Wire to Other Factors Indicative of Bone Quality

More than 250,000 hip fractures occur annually in the United States and the most common fracture location is the femoral neck, the weakest region of the femur. Hip fixation surgery is conducted to repair hip fractures by using a Kirschner (K-) wire as a temporary guide for permanent bone screws. Variation has been observed in the force required to extract the K-wire from the femoral head during surgery. It is hypothesized that a relationship exists between the K-wire pullout force and the bone quality at the site of extraction. Currently, bone mineral density (BMD) is used as a predictor for bone quality and strength. However, BMD characterizes the entire skeletal system and does not account for localized bone quality and factors such as lifestyle, nutrition, and drug use. A patient’s BMD may not accurately describe the quality of bone at the site of fracture. This study aims to investigate a correlation between the force required to extract a K-wire from femoral head specimens and the quality of bone. A procedure to measure K-wire pullout force was developed and tested with pig femoral head specimens. The procedure was implemented on 8 human osteoarthritic femoral head specimens and the average pullout force for each ranged from 563.32 ± 240.38 N to 1041.01 ± 346.84 N. The data exhibited significant variation within and between each specimen and no statistically significant relationships were determined between pullout force and patient age, weight, height, BMI, inorganic to organic matter ratio, and BMD. A new testing fixture was designed and manufactured to merge the clinical and research environments by enabling the physician to extract the K-wire from each bone specimen himself. The new device allows the physician to gather tactile feedback on the relative ease of extraction while load history is recorded similar to the previous procedure for data acquisition. Future work will include testing human bones with the new device to further investigate correlations for predicting bone quality.

Novel bone-anchored vascular access on the mastoid for hemodialysis: concept and preclinical trials

GOAL We present the development of a boneanchored port for the painless long-term hemodialytic treatment of patients with renal failure. This port is implanted behind the ear. METHODS The port was developed based on knowledge obtained from long-term experience with implantable hearing devices, which are firmly anchored to the bone behind the ear. This concept of bone anchoring was adapted to the requirements for a vascular access during hemodialysis. The investigational device is comprised of a base plate that is firmly fixed with bone screws to the bone behind the ear (temporal bone). A catheter leads from the base plate valve block through the internal jugular vein and into the right atrium. The valves are opened using a special disposable adapter, without any need to puncture the blood vessels. Between hemodialysis sessions the port is protected with a disposable cover. RESULTS Flow rate, leak tightness and purification were tested on mockups. Preoperative planning and the surgical procedure were verified in 15 anatomical human whole head specimens. CONCLUSION Preclinical evaluations demonstrated the technical feasibility and safety of the investigational device. SIGNIFICANCE Approximately 1.5 million people are treated with hemodialysis worldwide, and 25% of the overall cost of dialysis therapy results from vascular access problems. New approaches towards enhancing vascular access could potentially reduce the costs and complications of hemodialytic therapy.

A prototype bone screw design for osteoporotic bone

Poster. Introduction: One in five menand one half of women over the age of 50 will experience a bone fracture, whichis frequently accompanied by poor bone health. This combination of poor bonehealth and fracture is a two edge sword, because not only does poor bone healthmake fractures more likely, it also reduces the efficacy of standard fracturetreatments. Currently available surgical fixation devices that were originallydeveloped for healthy bone, such as pins, plates and bone screws, are often noteffective for patients with osteoporosis, resulting in unsatisfactory outcomesor longer and more painful recovery times. One major issue is the design ofbone screws, which can loosen or pull-out from osteoporotic bone. Osteopenicscrews with larger outer thread diameters have been developed to try andaddress this problem. The larger diameter screws have been shown to be 60–70 %stronger in lab tests of individual screws but the larger diameter screwscannot be used with the standard spacing in fixation plates without the risk ofcausing fractures between the screws. In addition, many fractures occur nearjoints where there is not room to increase the spacing between screws.Therefore, new bone screws are needed for treatment of fractures in osteoporoticbone. Materials and Methods: Afterdeveloping a novel bone screw design, we fabricated screws using rapidprototyping methods. Screws were inserted into 10 pcf density sawbones polyurethanefoam as a model for osteoporotic bone. Pull-out tests were conducted using theprototype bone screw design and the standard screw design for comparison inaccordance with ASTM 543-13. Results and Discussion: Ourprototype screws have the same outer diameter as standard bone screws, but haveoptimised threads. For pull-out tests in 10 psf density sawbones poly-urethanefoam, the prototype screw design was 60 % stronger than the standard bone screwdesign (p<0.01). Conclusion: Our novel bonescrew design provides significant improvement in standard tests with syntheticbone material. Additional tests are needed to determine if the bone screwswould be suitable for human trials.

Biomechanical in vitro evaluation of three stable internal fixation techniques used in sagittal osteotomy of the mandibular ramus: a study in sheep mandibles

Among the osteotomies performed in orthognathic surgery, the sagittal osteotomy of the mandibular ramus (SOMR) is the most common, allowing a great range of movements and stable internal fixation (SIF), therefore eliminating the need of maxillomandibular block in the postoperative period. Objectives: The purpose of this study was to evaluate the biomechanical resistance of three national systems used for SIF in SOMR in sheep mandibles. Material and methods: The study was performed in 30 sheep hemi-mandibles randomly divided into 3 experimental groups, each containing 10 hemi-mandibles. The samples were measured to avoid discrepancies and then subjected to SOMR with 5-mm advancement. In group I, 2.0x12 mm screws were used for fixation, inserted in an inverted "L" pattern (inverted "L" group). In group II, fixation was performed with two 2.0x12 mm screws, positioned in a linear pattern and a 4-hole straight miniplate and four 2.0x6.0 mm monocortical screws (hybrid group). In group III, fixation was performed with two-hole straight miniplates and eight 2.0x6.0 mm monocortical screws (mini plate group). All materials used for SIF were supplied by Osteosin - SIN. The hemimandibles were subjected to vertical linear load test by Kratos K2000MP mechanical testing unit for loading registration and displacement. Results: All groups showed similar resistance during mechanical test for loading and displacement, with no statistically significant differences between groups according to analysis of variance. Conclusion: These results indicate that the three techniques of fixation are equally effective for clinical fixation of SOMR.

Avaliação tomográfica dos pedículos vertebrais no tratamento cirúrgico dos pacientes com escoliose idiopática do adolescente

OBJETIVO: Determinar através de cortes tomográficos e reconstrução tridimensional a incidência de mal posicionamento de parafusos em pacientes submetidos ao tratamento cirúrgico da Escoliose idiopática do adolescente. MÉTODOS: Foram analisados exames tomográficos de 8 pacientes, tratados cirurgicamente no Hospital de Base de São José do Rio Preto-SP, realizada instrumentação posterior partindo de T2 /T4 a L4/L5 totalizando 164 parafusos. RESULTADOS: 32,9% (n=54) apresentavam posicionamento com risco potencial,ou seja desvio acima de 2 milímetros, sendo 20,1% (n=33) com invasão lateral, 9,1% (n=15) com invasão medial, 3,6 %(n=6) com invasão anterior. Dos parafusos que ofereciam risco potencial a relação com aspecto da curva foi de 46% (n=25) na concavidade, 35% (n=19) na convexidade e 19% (n=10) em vértebras adjacentes a curva. CONCLUSÃO: Os limites de penetração aceitáveis, assim como os métodos de mensuração ainda não foram padronizados, a técnica free hand' mostrou-se segura, apesar da violação dos pedículos. A tomografia computadorizada pré-operatória, auxilia no planejamento cirúrgico e na redução das complicações.

Estudo histomorfométrico da influência do diâmetro do orifício piloto na interface entre o implante e o osso vertebral

OBJETIVO: Estudar as alterações agudas da interface entre os parafusos e o tecido ósseo vertebral, considerando o diâmetro do orifício-piloto em relação ao diâmetro interno do parafuso. MÉTODOS: O estudo foi realizado em carneiros e a segunda vértebra cervical selecionada para o estudo. Foram utilizados parafusos corticais de 3,5mm de diâmetro externo (2,4mm de diâmetro interno) e 14mm de comprimento. Foram formados quatro grupos experimentais: 1) orifício-piloto de 2,0mm e colocação do parafuso de 3,5mm; 2) orifício-piloto de 2,5mm e colocação do parafuso de 2,5mm; 3) orifício-piloto de 2mm sem colocação do parafuso; e 4) orifício-piloto de 2,5mm sem colocação do parafuso. RESULTADOS: O grupo 1 (orifício-piloto menor do que o diâmetro interno do parafuso) apresentou maior densidade óssea no interior da rosca do implante e maior densidade óssea na área em espelho do que o grupo 2 (orifício-piloto maior que o diâmetro interno do parafuso). A superfície de contato entre o tecido ósseo e o implante foi maior no grupo 2 em relação ao grupo 1. A comparação da densidade óssea na área em espelho entre os grupos com e sem implante (1 e 3) e (2 e 4) mostrou que a densidade óssea era maior nos grupos com o implante. Não foi observada diferença estatística entre as comparações dos grupos experimentais. CONCLUSÃO: A utilização de orifício-piloto de menor diâmetro em relação ao diâmetro interno do parafuso apresentou tendência a provocar maior compactação do osso ao redor do implante.

Comparação entre parafuso de interferência e transcondilar na reconstrução do LCA

OBJETIVO: A fixação femoral na reconstrução do Ligamento Cruzado Anterior (LCA) com enxerto de tendões flexores pode variar muito de acordo com a disposição dos materiais e a experiência do cirurgião. Porém os trabalhos que comparam os sistemas de fixação são efetuados na maioria das vezes em cadáveres ou em animais, sem avaliar os resultados clínicos, prejudicando sua comparação com pacientes humanos vivos. Neste artigo avaliamos o resultado clínico de dois métodos de fixação do enxerto ao fêmur (parafuso de interferência de titânio e parafuso transcondilar de titânio) para saber se, do ponto de vista clinico e subjetivo, há diferença entre estes métodos. MÉTODOS: Foram selecionados 40 pacientes com lesão do LCA sendo que 20 pacientes tiveram seu enxerto fixado ao fêmur com parafuso de interferência e 20 com parafuso transcondilar. Todos foram reavaliados com no mínimo dois anos de pós operatório para medição da gaveta anterior, Pivot Shift e teste de Lachman, além da obtenção dos questionário de Lysholm e IKDC (International Knee Documentation Committee). RESULTADOS: Os resultados não foram estatisticamente diferentes para os critérios avaliados. CONCLUSÃO: As duas formas de fixação são eficientes para esta técnica dentro dos parâmetros estabelecidos. Nível de Evidência II, Estudo Prospectivo Comparativo.

Rigid internal fixation with titanium versus bioresorbable miniplates in the repair of mandibular fractures in rabbits

The purpose of this study was to compare by qualitative histology the efficacy of rigid internal fixation with titanium system and the Lacto Sorb® system in mandibular fractures in rabbits. Thirty male adult rabbits Oryctolagus cuniculus were used. Unilateral mandibular osteotomies were performed between the canine and first premolar. The animals were divided into two groups: for Group I - rigid internal fixation was performed with titanium system 1.5 mm (Synthes, Oberdorf, Switzerland), with two screws of 6 mm (bicortical) on each side of the osteotomy. For Group II-rigid internal fixation was performed with PLLA/PGA system 1.5 mm (Lacto Sorb®, WLorenz, Jacksonville, FL, USA). The histological analysis evaluated the presence of inflammatory reaction, degree of bone healing and degree of resorption of the Lacto Sorb® screws. The results of both fixation systems were similar, only with a small difference after 15 and 30 days. In Group I a faster bony healing was noted. But after 60 days, bony healing was similar in both groups. It is concluded that both PLLA/PGA and titanium plates and screws provide sufficient strength to permit mandibular bone healing. The resorption process of PLLA/PGA osteosynthesis material did not cause acute or chronic inflammatory reaction or foreign body reaction during the studied period. © 2004 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

The effect of locked screw angulation on the biomechanical properties of the S.P.S. Free-Block plate

Objectives: Among the locked internal fixators is one denominated S.P.S. (Synthesis Pengo System) Free-Block, which was designed with a locking ring that allows the screw to be locked and positioned obliquely. Due to the paucity of biomechanical studies on this system, the present work aimed to evaluate the influence of locked screw angulation on the resistance of the S.P.S. Free--Block plate. Methods: Forty synthetic bone cylinders with 10 mm fracture gap were used. Forty seven-hole 3.5 mm stainless steel plates (two AO-like dynamic compression holes and five locked holes) were assembled according to the orientation of the locked screws: mono cortical screws were positioned at 90° to the long axis of the cylinder (Group 1), and monocortical screws were positioned at 70° to its cylinder long axis (Group 2). In both groups, AO-like dynamic compression hole screws were positioned bicortically and neutrally. For each group, six specimens were tested until failure, three in bending and three in compression, to determine the loads for fatigue testing. Subsequently, for each group, 14 specimens were tested for failure --seven by bending and seven in compression. Results: No significant failure differences were observed between Groups 1 and 2 under static-loading or fatigue test. Clinical significance: In a fracture gap model the orientation of the locked monocortical screws did not show any influence on the mechanical performance of the S.P.S. Free-Block to tests of axial compression and four-point bending. © Schattauer 2013.

Biomechanical in vitro evaluation of three stable internal fixation techniques used in sagittal osteotomy of the mandibular ramus: a study in sheep mandibles

Among the osteotomies performed in orthognathic surgery, the sagittal osteotomy of the mandibular ramus (SOMR) is the most common, allowing a great range of movements and stable internal fixation (SIF), therefore eliminating the need of maxillomandibular block in the postoperative period. Objectives: The purpose of this study was to evaluate the biomechanical resistance of three national systems used for SIF in SOMR in sheep mandibles. Material and methods: The study was performed in 30 sheep hemi-mandibles randomly divided into 3 experimental groups, each containing 10 hemi-mandibles. The samples were measured to avoid discrepancies and then subjected to SOMR with 5-mm advancement. In group I, 2.0x12 mm screws were used for fixation, inserted in an inverted "L" pattern (inverted "L" group). In group II, fixation was performed with two 2.0x12 mm screws, positioned in a linear pattern and a 4-hole straight miniplate and four 2.0x6.0 mm monocortical screws (hybrid group). In group III, fixation was performed with two-hole straight miniplates and eight 2.0x6.0 mm monocortical screws (mini plate group). All materials used for SIF were supplied by Osteosin - SIN. The hemimandibles were subjected to vertical linear load test by Kratos K2000MP mechanical testing unit for loading registration and displacement. Results: All groups showed similar resistance during mechanical test for loading and displacement, with no statistically significant differences between groups according to analysis of variance. Conclusion: These results indicate that the three techniques of fixation are equally effective for clinical fixation of SOMR.

Biological monitoring of a promissory xenogenic pin for biomedical applications: a preliminary intraosseous study in rats

Objectives: Over the last years, it is known that in some cases metal devices for biomedical applications present some disadvantages suggesting absorbable materials (natural or synthetic) as an alternative of choice. Here, our goal was to evaluate the biological response of a xenogenic pin, derived from bovine cortical bone, intraosseously implanted in the femur of rats. Material and methods: After 10, 14, 30 and 60 days from implantation, the animals (n = 5/period) were killed and the femurs carefully collected and dissected out under histological demands. For identifying the osteoclastogenesis level at 60 days, we performed the immunohistochemisty approach using antibody against RANKL. Results: Interestingly, our results showed that the incidence of neutrophils and leukocytes was observed only at the beginning (10 days). Clear evidences of pin degradation by host cells started at 14 days and it was more intensive at 60 days, when we detected the majority of the presence of giant multinucleated cells, which were very similar to osteoclast cells contacting the implanted pin. To check osteoclastogenesis at 60 days, we evaluated RANKL expression and it was positive for those resident multinucleated cells while a new bone deposition was verified surrounding the pins in all evaluated periods. Conclusions: Altogether, our results showed that pins from fully processed bovine bone are biocompatible and absorbable, allowing bone neoformation and it is a promissory device for biomedical applications.

TOMOGRAPHIC ANALYSIS OF ANATOMICAL PARAMETERS OF THE AXIS IN CHILDREN

Objective: To carry out an anatomical study of the axis with the use of computed tomography (CT) in children aged from two to ten years, measuring the lamina angle, lamina and pedicle length and thickness, and lateral mass length. Methods: Sixty-four CTs were studied from patients aged 24 to 120 months old, of both sexes and without any cervical anomaly. The measurements obtained were correlated with the data on age and sex of the patients. Statistical analysis was performed using the Students "t" tests. Results: We found that within the age range 24-48 months, 5.5% of the lamina and 8.3% of the pedicles had thicknesses of less than 3.5mm, which is the minimum thickness needed for insertion of the screw. Between 49 and 120 months, there were no lamina thicknesses of less than 3.5mm, and 1.2% of the pedicle thicknesses were less than 3.5mm values. Neither of the age groups had any lamina and pedicle lengths of less than 12mm, or lateral mass lengths greater than 12mm. Conclusion: The analysis of the data obtained demonstrates that most of the time, is possible to use a 3.5mm pedicle screw in the laminas and pedicles of the axis in children. Level of Evidence: II, Development of diagnostic criteria in consecutive patients.