Complex distal humerus fractures-comparison of polyaxial locking and nonlocking screw configurations-a preliminary biomechanical study.

OBJECTIVE: The investigation hypothesized that in current anatomical precontoured plates, angular stability plays only a minor role for the efficacy of the osteosynthesis at the distal humerus. METHODS: An AO C2.3 fracture model was simulated and osteosynthesis performed with plates positioned in parallel. System rigidity and median fatigue limit were analyzed in artificial bones and the cycles to failure in cadaver specimens. Loads were applied in anterior-posterior direction (75° flexion) and axial direction (5° flexion). Four composite bone groups were investigated as follows: (1) 2.7 mm polyaxial locking screws, (2) 3.5 mm polyaxial locking screws, (3) 3.5 mm polyaxial locking screws and a gap bridging screw, and (4) 2.7 mm nonlocking screws. Two cadaver groups were investigated with 3.5 mm diameter polyaxial locking (5) versus nonlocking screws (6). RESULTS: There were no differences in stiffness found between the locking versus nonlocking constructs in artificial (1) versus (4) and in cadaver bones (5) versus (6). The larger screw diameter of 3.5 mm in combination with a gap bridging screw significantly increased construct stiffness by 25% (3). The median fatigue limit was significantly increased using larger screw diameters (2) and a gap bridging screw (3). In cadaver bones, the polyaxial locking screws constructs (5) resisted higher peak loads and more cycles until failure compared with nonlocking constructs (6). CONCLUSIONS: System stiffness increases with larger screw diameters and becomes significant with additional gap bridging screws in artificial bones. The use of polyaxial locking screws in anatomical adapted plates becomes more important in poor bone quality.

Repair of large segmental bone defects: BMP-2 gene activated muscle grafts vs. autologous bone grafting.

BACKGROUND: Common cell based strategies for the treatment of osseous defects require the isolation and expansion of autologous cells. Since this makes such approaches time-consuming and expensive, we developed a novel expedited technology creating gene activated muscle grafts. We have previously shown that large segmental bone defects in rats can be regenerated by implantation of muscle tissue fragments activated by BMP-2 gene transfer. RESULTS: In the present study, we compared the bone healing capacities of such gene activated muscle grafts with bone isografts, mimicking autologous bone grafting, the clinical gold standard for treatment of bone defects in patients. Two of 14 male, syngeneic Fischer 344 rats used for this experiment served as donors for muscle and bone. Muscle tissue was harvested from both hind limbs and incubated with an adenoviral vector carrying the cDNA encoding BMP-2. Bone was harvested from the iliac crest and long bone epiphyses. Bone defects (5 mm) were created in the right femora of 12 rats and were filled with either BMP-2 activated muscle tissue or bone grafts. After eight weeks, femora were evaluated by radiographs, micro-computed tomography (µCT), and biomechanical testing. In the group receiving BMP-2 activated muscle grafts as well as in the bone-grafting group, 100% of the bone defects were healed, as documented by radiographs and µCT-imaging. Bone volume was similar in both groups and biomechanical stability of the two groups was statistically indistinguishable. CONCLUSIONS: This study demonstrates that treatment of large bone defects by implantation of BMP-2 gene activated muscle tissue leads to similar bone volume and stability as bone isografts, mimicking autologous bone grafting.

Implant material and design alter construct stiffness in distal femur locking plate fixation: a pilot study.

BACKGROUND: Construct stiffness affects healing of bones fixed with locking plates. However, variable construct stiffness reported in the literature may be attributable to differing test configurations and direct comparisons may clarify these differences. QUESTIONS/PURPOSES: We therefore asked whether different distal femur locking plate systems and constructs will lead to different (1) axial and rotational stiffness and (2) fatigue under cyclic loading. METHODS: We investigated four plate systems for distal femur fixation (AxSOS, LCP, PERI-LOC, POLYAX) of differing designs and materials using bone substitutes in a distal femur fracture model (OTA/AO 33-A3). We created six constructs of each of the four plating systems. Stiffness under static and cyclic loading and fatigue under cyclic loading were measured. RESULTS: Mean construct stiffness under axial loading was highest for AxSOS (100.8 N/mm) followed by PERI-LOC (80.8 N/mm) and LCP (62.6 N/mm). POLYAX construct stiffness testing showed the lowest stiffness (51.7 N/mm) with 50% stiffness of AxSOS construct testing. Mean construct stiffness under torsional loading was similar in the group of AxSOS and PERI-LOC (3.40 Nm/degree versus 3.15 Nm/degree) and in the group of LCP and POLYAX (2.63 Nm/degree versus 2.56 Nm/degree). The fourth load level of > 75,000 cycles was reached by three of six AxSOS, three of six POLYAX, and two of six PERI-LOC constructs. All others including all LCP constructs failed earlier. CONCLUSIONS: Implant design and material of new-generation distal femur locking plate systems leads to a wide range of differences in construct stiffness. CLINICAL RELEVANCE: Assuming construct stiffness affects fracture healing, these data may influence surgical decision-making in choosing an implant system.

The impact of a distal expansion mechanism added to a standard pedicle screw on pullout resistance. A biomechanical study.

BACKGROUND CONTEXT: Spinal deformity surgery in elderly patients is associated with an increased risk of implant loosening due to failure at the screw-bone interface. Several techniques can be used to increase the screw anchorage characteristics. Cement-augmented screw fixation was shown to be the most efficient method; however, this technique is associated with a risk of complications related to vertebral cement deposition and leakage. Hence, there is a need to further elaborate the alternative screw augmenting techniques to reduce the indications for bone cement. PURPOSE: To analyze surgical alternatives to cement augmentation, the present study sought to quantify the impact of a distal expansion mechanism added to a standard pedicle screw on an axial pullout resistance. STUDY DESIGN: A biomechanical laboratory study on the uniaxial pullout resistance of a standard pedicle screw versus a customized pedicle screw with a distal expansion mechanism. METHODS: A total of 40 vertebrae from seven fresh-frozen human specimens were harvested and subjected to a computed tomography scanning and an analysis of the bone mineral density (BMD). The vertebrae were instrumented with a standard 6.0-mm pedicle screw and a modified 6.0-mm pedicle screw with a distal expansion mechanism added. The actual working length of both screws inside the vertebrae was identical. The distal expansion mechanism made up one-fifth of the shaft length. The accuracy of the screw insertion was assessed using biplanar radiographs and by inspection. Analysis of resistance to pullout was performed by a coaxial alignment of the pedicle screws and attachment to an electromechanical testing machine. The pullout rate was 5 mm/min, and the load-displacement curve was recorded until the force of the pullout resistance peaked. The peak load-to-failure was measured in Newtons and reported as the ultimate failure load. With each test, the mode of failure was noted and analyzed descriptively. RESULTS: A total of 17 vertebrae with matched pairs of standard and expansion pedicle screws were eligible for the final statistical analysis. The BMD of the vertebrae tested was 0.67±0.19 g/cm³. The screw length was 50 mm, and the actual working length of both screws was 40.3±4.2 mm. The ultimate failure load of the standard screw was 773.8±529.4 N and that of the expansion screw was 910.3±488.3 N. Statistical analysis revealed a strong trend toward an increased failure load with the expansion screw (p=.06). The mean increase of the ultimate failure load was 136.5±350.4 N. Abrupt vertebral fracture at the vertebral body-pedicle junction and the pedicle occurred seven times with the expansion screw and only five times with the standard screw (p=.16). CONCLUSIONS: Our study indicates that adding a distal expansion mechanism to a standard pedicle screw increases the failure load by one-fifth. Modern expansion screws might offer an intermediate solution for the augmentation of screw-rod constructs in osteoporotic bone while reducing the need for cement-augmented screws and avoiding the related risks.

Biomechanical evaluation of subtalar fusion: the influence of screw configuration and placement.

Common surgical procedures for subtalar fusion include joint resection, autologous bone grafting, and osteosynthesis with screws in a parallel screw configuration. Although fusion is a routine procedure, the reported rates of nonunion have been high. The present study assessed different screw configurations in terms of their rotational and bending stability in an artificial bone model and cadaver bone. Arthrodesis was always performed with 2 screws. Three different screw configurations were tested: parallel, counter-parallel, and a delta configuration. Two different screw designs were used: a cannulated, partially threaded screw (6.5-mm and 8.0-mm diameter) and a solid screw with a different thread design. Eight experimental groups were investigated as pilot studies in artificial bones and then 3 groups in cadaver bones. The parameters were the primary stiffness and deflection of the construct for loads simulating the internal-external rotation and supination-pronation. Delta positioning of the screws resulted in the greatest biomechanical stiffness and the lowest degrees of deflection of the arthrodesis in the artificial bones and cadaver bones. Increasing the screw diameter from 6.5 to 8.0 mm resulted in no additional stability of the arthrodesis in the artificial bones. The results of the present study have indicated that the delta configuration for arthrodesis results in the greatest construct stiffness and lower relative deflection between the talus and calcaneus in the positions tested.

Comparison of revision strategies for failed C2-posterior cervical pedicle screws: a biomechanical study.

STUDY PURPOSE: With increasing usage within challenging biomechanical constructs, failures of C2 posterior cervical pedicle screws (C2-pCPSs) will occur. The purpose of the study was therefore to investigate the biomechanical characteristics of two revision techniques after the failure of C2-pCPSs. MATERIALS AND METHODS: Twelve human C2 vertebrae were tested in vitro in a biomechanical study to compare two strategies for revision screws after failure of C2-pCPSs. C2 pedicles were instrumented using unicortical 3.5-mm CPS bilaterally (Synapse/Synthes, Switzerland). Insertion accuracy was verified by fluoroscopy. C2 vertebrae were potted and fixed in an electromechanical testing machine with the screw axis coaxial to the pullout direction. Pullout testing was conducted with load and displacement data taken continuously. The peak load to failure was measured in newtons (N) and is reported as the pullout resistance (POR). After pullout, two revision strategies were tested in each vertebra. In Group-1, revision was performed with 4.0-mm C2-pCPSs. In Group-2, revision was performed with C2-pedicle bone-plastic combined with the use of a 4-mm C2-pCPSs. For the statistical analysis, the POR between screws was compared using absolute values (N) and the POR of the revision techniques normalized to that of the primary procedures (%). RESULTS: The POR of primary 3.5-mm CPSs was 1,140.5 ± 539.6 N for Group-1 and 1,007.7 ± 362.5 N for Group-2; the difference was not significant. In the revision setting, the POR in Group-1 was 705.8 ± 449.1 N, representing a reduction of 38.1 ± 32.9 % compared with that of primary screw fixation. For Group-2, the POR was 875.3 ± 367.9 N, representing a reduction of 13.1 ± 23.4 %. A statistical analysis showed a significantly higher POR for Group-2 compared with Group-1 (p = 0.02). Although the statistics showed a significantly reduced POR for both revision strategies compared with primary fixation (p < 0.001/p = 0.001), the loss of POR (in %) in Group-1 was significantly higher compared with the loss in Group-2 (p = 0.04). CONCLUSIONS: Using a larger-diameter screw combined with the application of a pedicle bone-plastic, the POR can be significantly increased compared with the use of only an increased screw diameter.

Arthroscopic rotator cuff repair: a biomechanical comparison of the suture-bridge technique vs. a new transosseous technique using SutureButtons(®).

BACKGROUND: The suture-bridge technique using anchors as established transosseous-equivalent technique in arthroscopic rotator cuff repair was compared to a modified transosseous technique suitable for arthroscopic cuff repair. METHODS: In 10 fresh-frozen matched pairs of human cadaveric shoulders (mean age 67.1, SD 8.5 years), two different surgical techniques of cuff repair were tested: Group 1, using the suture-bridge technique with suture anchors, and Group 2, using two transosseous tunnels with SutureButtons(®). Lateral row fixation was performed in both groups using knotless implants. Cyclic displacement to gap formation of 2 and 5mm, linear stiffness, yield load, ultimate load, and mode of failure were recorded. FINDINGS: Gap formation at the tendon-to-bone interface of 2mm occurred after a mean of 219.5 (SD 590.7) cycles in Group 1 and after 750.0 (SD 1566.1) cycles in Group 2. Gap formation of 5mm occurred after 2331.6 (SD 2033.9) cycles (Group 1) and 2364.5 (SD 1994.2) cycles (Group 2), respectively. The yield and ultimate loads were 316.9 (SD 114.1)N and 375.9 (SD 131.2)N in Group 1, and 311.0 (SD 97.2)N and 363.8 (SD 107.6)N in Group 2, respectively. The linear stiffness was 40.3 (SD 10.4)N/mm in Group 1, and 41.6 (SD 13.2)N/mm in Group 2. There were no statistically significant intergroup differences. INTERPRETATION: The new transosseous technique using SutureButtons(®) achieves equivalent biomechanical properties to the established suture-bridge technique using anchors. A tendentially reduced primary gap formation may be of importance for repair healing during the early phase of rehabilitation.

Biomechanical comparison of the end plate design of three vertebral body replacement systems.

INTRODUCTION: Compression fractures at the thoracolumbar junction are frequently treated by reconstruction with vertebral body replacement systems. Modern cage implants have been developed which respect the anatomy and angulation of the adjacent bony endplates. The objective of this study was to investigate the biomechanical performance of anatomic endplate design and variable endplate angulation. MATERIALS AND METHODS: Three cage systems [Hydrolift (HYL), Aesculap; Synex II (SYN), Synthes; Obelisc (OBC), Ulrich] were compared employing a composite bone substitute material at two levels of endplate angulation (0°, 3°). Their load-bearing capacity was assessed in a physiologic test with human vertebral specimens in a misalignment situation (3°). The HYL and SYN offered anatomically shaped endplates. The endplates of the HYL had variable angulation during insertion and were then mechanically fixated. The OBC had fixed and circular endplates. The load to failure and system stiffness were evaluated by an axial compression test. The bone mineral density (BMD) and the area of the bony endplates were measured via CT. RESULTS: None of the mechanical properties differed between 0° and 3° for the HYL cage using bone substitute material, while the OBC lost 19% of the failure load (p = 0.001) and 55% of stiffness (p = 0.001) in case of misalignment. In human bone specimens, failure loads were comparable among all implants (p > 0.1) with the HYL showing the largest system stiffness (p < 0.05). Furthermore, a strong correlation between stiffness and BMD (R(2) = 0.82) and failure load and BMD (R(2) = 0.87) was found. CONCLUSION: Anatomically shaped and continuously variable endplates provide mechanical advantages under imperfect alignment and may thus reduce secondary dislocation and the loss of correction. This is achieved by retaining an optimal contact area between the implant and the bony endplates. Conventional cage design with circular endplates offer adequate stability in optimal contact situations.

Improvement of the shear fixation stability of intramedullary nailing.

BACKGROUND: The healing outcome of long bone fractures is strongly influenced by the mechanical environment. High interfragmentary movement at the fracture site is detrimental to the fracture healing process. Long bone fractures stabilized with thin intramedullary nails commonly used for unreamed intramedullary nailing might be very flexible in shear direction and therefore critical for the fracture healing outcome. The aims of this study were to simulate the shear interfragmentary movement during gait for a human tibia treated with intramedullary nailing and to investigate if this movement could be lowered by implant design modifications. METHODS: The shear movement was calculated with a 3D finite element model based on computer tomograph images of a cadaver bone-implant complex of a transverse tibia fracture treated with a Stryker T2 Standard Tibial Nail. This model was validated through in vitro test results under pure shear, axial, bending and torsional loading. FINDINGS: High shear movements of approximately 4mm were calculated during gait. These shear movements could be reduced by approximately 30% either by implant modifications or the use of a 1mm thicker nail. Combining the implant modifications with a 1mm thicker nail, the shear movements could be reduced by 54%. INTERPRETATION: The increase of the fixation stiffness by using an implant material with a high Young's modulus in combination with an angle-stable nail-screw fixation helps to reduce the shear movement during gait and possibly to lower the risk of a prolonged healing time with unreamed intramedullary nailing.

Anatomical plate configuration affects mechanical performance in distal humerus fractures.

BACKGROUND: Because of strong loads acting in the elbow joint, intraarticular fractures with a methaphyseal comminuted fracture site at the distal humerus demand a lot from the osteosynthetic care. Ambiguities arise concerning to the anatomic position of the implants and the resulting mechanic performance. The aim of this biomechanical study was to compare the performance of different anatomical plate configurations for fixation of comminuted distal humerus fractures within one system. METHODS: In an artificial bone model two perpendicular and one parallel plating configuration of a dedicated elbow plating system were compared with respect to system rigidity (flexion and extension) and dynamic median fatigue limit (extension). The flexion tests were conducted under 75° and the extension tests under 5°. Furthermore, the relative displacements were recorded. As a fracture model an AO C 2.3-fracture on an artificial bone (4th Gen. Sawbone) was simulated via double osteotomy in sagittal and transversal plane. FINDINGS: Large differences in mechanical performance were observed between flexion and extension loading modes. In extension the parallel configuration with lateral and medial plates achieved the highest bending stiffness and median fatigue limit. In flexion the highest bending stiffness was reached by the construct with a medial and a postero-lateral plate. Failure of the implant system predominantly occurred at the screw-bone interface or by fatigue of the plate around the screw holes. INTERPRETATION: All three plate configurations provided sufficient mechanical stability to allow early postoperative rehabilitation with a reduced loading protocol. Although the individual fracture pattern determines the choice of plate configuration, the parallel configuration with lateral and medial plates revealed biomechanical advantages in extension only.

A biomechanical rationale for C1-ring osteosynthesis as treatment for displaced Jefferson burst fractures with incompetency of the transverse atlantal ligament.

Nonsurgical treatment of Jefferson burst fractures (JBF) confers increased rates of C1-2 malunion with potential for cranial settling and neurologic sequels. Hence, fusion C1-2 was recognized as the superior treatment for displaced JBF, but sacrifies C1-2 motion. Ruf et al. introduced the C1-ring osteosynthesis (C1-RO). First results were favorable, but C1-RO was not without criticism due to the lack of clinical and biomechanical data serving evidence that C1-RO is safe in displaced JBF with proven rupture of the transverse atlantal ligament (TAL). Therefore, our objectives were to perform a biomechanical analysis of C1-RO for the treatment of displaced Jefferson burst fractures (JBF) with incompetency of the TAL. Five specimens C0-2 were subjected to loading with posteroanterior force transmission in an electromechanical testing machine (ETM). With the TAL left intact, loads were applied posteriorly via the C1-RO ramping from 10 to 100 N. Atlantoaxial subluxation was measured radiographically in terms of the anterior antlantodental interval (AADI) with an image intensifier placed surrounding the ETM. Load-displacement data were also recorded by the ETM. After testing the TAL-intact state, the atlas was osteotomized yielding for a JBF, the TAL and left lateral joint capsule were cut and the C1-RO was accomplished. The C1-RO was subjected to cyclic loading, ramping from 20 to 100 N to simulate post-surgery in vivo loading. Afterwards incremental loading (10-100 N) was repeated with subsequent increase in loads until failure occurred. Small differences (1-1.5 mm) existed between the radiographic AADI under incremental loading (10-100 N) with the TAL-intact as compared to the TAL-disrupted state. Significant differences existed for the beginning of loading (10 N, P = 0.02). Under physiological loads, the increase in the AADI within the incremental steps (10-100 N) was not significantly different between TAL-disrupted and TAL-intact state. Analysis of failure load (FL) testing showed no significant differences among the radiologically assessed displacement data (AADI) and that of the ETM (P = 0.5). FL was Ø297.5 +/- 108.5 N (range 158.8-449.0 N). The related displacement assessed by the ETM was Ø5.8 +/- 2.8 mm (range 2.3-7.9). All specimens succeeded a FL >150 N, four of them >250 N and three of them >300 N. In the TAL-disrupted state loads up to 100 N were transferred to C1, but the radiographic AADI did not exceed 5 mm in any specimen. In conclusion, reconstruction after displaced JBF with TAL and one capsule disrupted using a C1-RO involves imparting an axial tensile force to lift C0 into proper alignment to the C1-2 complex. Simultaneous compressive forces on the C1-lateral masses and occipital condyles allow for the recreation of the functional C0-2 ligamentous tension band and height. We demonstrated that under physiological loads, the C1-RO restores sufficient stability at C1-2 preventing significant translation. C1-RO might be a valid alternative for the treatment of displaced JBF in comparison to fusion of C1-2.

The repair of critical-sized bone defects using expedited, autologous BMP-2 gene-activated fat implants.

The repair of bone defects can be induced experimentally with bone morphogenetic protein-2 (BMP-2) producing fat-derived stem cells, but this ex vivo tissue engineering method requires the isolation and long-term culture of autologous cells. To develop an expedited bone repair strategy, we transferred BMP-2 cDNA directly to autologous fat tissue fragments that were held in culture for only 24 h before implantation. We evaluated the ability of such gene-activated fat grafts to regenerate large segmental bone defects in rats. Fat tissue was harvested from 2 of 35 male Fischer 344 rats used for this study. The fat tissue fragments were incubated with an adenoviral vector carrying the cDNA encoding either BMP-2 or green florescent protein (GFP), or they remained unmodified. According to their group, the segmental femoral bone defects of 33 rats were filled press fit with either BMP-2-activated fat tissue, GFP-transduced fat tissue, or unmodified fat tissue. Another control group remained untreated. Femora were evaluated by radiographs, microcomputed tomography, biomechanical torsional testing, and histology. Radiographically and histologically, 100% of the femora treated with BMP-2-activated fat grafts were bridged at 6 weeks after surgery. The femora of this group exceeded the bone volume and the biomechanical stability of intact, contralateral femora. Control defects receiving no treatment, unmodified fat tissue, or GFP-transduced fat were filled with fibrous or adipose tissue, as evaluated by histology. The use of BMP-2 gene-activated fat tissue grafts represents an expedited and effective bone repair strategy that does not require the extraction and expansion of stem cells.

Healing of large segmental bone defects induced by expedited bone morphogenetic protein-2 gene-activated, syngeneic muscle grafts.

Numerous preclinical studies have shown that osseous defects can be repaired by implanting bone morphogenetic protein (BMP)-2-transduced muscle cells. However, the drawback of this treatment modality is that it requires the isolation and long-term (approximately 3 weeks) culture of transduced autologous cells, which makes this approach cumbersome, time-consuming, and expensive. Therefore, we transferred BMP-2 cDNA directly to muscle tissue fragments that were held in culture for only 24 hr before implantation. We evaluated the ability of such gene-activated muscle grafts to induce bone repair. Two of 35 male, syngeneic Fischer 344 rats used in this study served as donors for muscle tissue. The muscle fragments remained unmodified or were incubated with an adenoviral vector carrying the cDNA encoding either green fluorescent protein (GFP) or BMP-2. Critical-size defects were created in the right femora of 33 rats and remained untreated or were filled (press fitted) with either unmodified muscle tissue or GFP-transduced muscle tissue or with BMP-2-activated muscle tissue. After 6 weeks, femora were evaluated by radiography, microcomputed tomography (muCT), histology, and biomechanical testing. Six weeks after implantation of BMP-2-activated muscle grafts, 100% of the bone defects were bridged, as documented by radiographs and muCT imaging, and showed formation of a neocortex, as evaluated by histology. Bone volumes of the femora repaired by BMP-2-transduced muscle were significantly (p = 0.006) higher compared with those of intact femora and the biomechanical stability was statistically indistinguishable. In contrast, control defects receiving no treatment, unmodified muscle, or GFP-transduced muscle did not heal. BMP-2 gene-activated muscle grafts are osteoregenerative composites that provide an expedited means of treating and subsequently healing large segmental bone defects.

Influence of intramedullary nail diameter and locking mode on the stability of tibial shaft fracture fixation.

BACKGROUND: Fracture healing is affected by the type and the magnitude of movements at the fracture site. Mechanical conditions will be a function of the type of fracture management, the distance between the fracture fragments, and the loading of the fracture site. The hypothesis to be tested was that the use of a larger-diameter intramedullary nail, together with compressed interlocking, would enhance the primary stiffness and reduce fracture site movements, especially those engendered by shearing forces. MATERIALS AND METHODS: Six pairs of human tibiae were used to study the influence on fracture site stability of two different diameters (9 and 11 mm) of intramedullary nails, in tension/compression, torsional, four-point bending, and shear tests. The nails were used with two interlocking modes (static interlocking vs. dynamic compression). RESULTS: With static interlocking, the 11-mm-diameter nail provided significantly (30-59%) greater reduction of fracture site movement, as compared with the 9-mm-diameter nail. Using an 11-mm-diameter nail, the stiffness of the bone-implant construct was enhanced by between 20 and 50%. Dynamic compression allowed the interfragmentary movements at the fracture site to be further reduced by up to 79% and the system stiffness to be increased by up to 80%. CONCLUSION: On biomechanical grounds, the largest possible nail diameter should be used, with minimal reaming, so as to minimize fracture site movement. Compression after meticulous reduction should be considered in axially stable fractures.

Influence of thread design on pedicle screw fixation. Laboratory investigation.

OBJECT: The authors conducted a study to determine the thread properties that provide optimal screw fixation in cancellous bone, when screws of the same external screw diameter are used. METHODS: Three compliance engineering-certified screws in clinical use, all of the same external diameter and length, were compared in an axial pullout experiment with respect to advantageous thread properties. As test material, standardized Sawbone blocks with 3 different densities (0.12, 0.16, and 0.32 g/cm3) were used. RESULTS: Screw thread Type 1, whose flank overlap area (FOA; 261 mm2) results from narrowing the conical core in the thread area, showed significantly better holding strength than the other types. Screw thread Type 2 (FOA 326 mm2) with a conical but thicker core and a smaller thread pitch was found to be the only one without increase of pull-out forces when test materials density changed from 0.12 to 0.16 g/cm3. A screw tested as control, with a constant (cylindrical) core diameter (Type 3; FOA 206 mm2), had the same thread pitch as Type 1 but without the compressive effect on the surrounding bur hole wall material. Nevertheless, it showed higher pullout forces in the 0.16-g/cm3 material than screw Type 2. CONCLUSIONS: By reducing the core diameter of a screw toward the tip, while maintaining a constant nominal (external) diameter, one achieves frictional connection due to compression of surrounding material. In addition, the FOA is increased, which, in summary, leads to better fixation, as shown by screw Type 1.

Validation of a femoral critical size defect model for orthotopic evaluation of bone healing: a biomechanical, veterinary and trauma surgical perspective.

Numerous in vivo studies have been conducted to investigate bone regeneration in orthotopic defect models, but a reliably standardized critical-size defect (CSD) model in small animals is still lacking in tissue-engineering research. Utilizing the expertise of trauma surgeons, veterinary surgeons, and engineers, we evaluated the optimal fixation strategy for in vivo application in terms of surgical suitability and conducted biomechanical studies for 3 fixation devices. Fixation strategies were an external fixation device made of polymethylmethacrylate, widely used in animal care; a self-constructed external clamp-fixation device, designed and manufactured using rapid prototyping techniques; and commercially available 1.2-mm titanium plates used in hand surgery. The CSD was 6 mm in size. Biomechanical testing included compression, 4-point bending, and torsion tests. The surgical procedure was optimized in vitro and validated in a clinical setting in athymic rats in vivo. Despite differences in the results of the biomechanical tests, all fixation devices tested proved suitable for the intended purpose. In conclusion, the evaluated model for stabilizing a CSD in a rat's femur can reliably be used for standardized bone regeneration studies in small animals.

Interfragmentary movement in diaphyseal tibia fractures fixed with locked intramedullary nails.

OBJECTIVES: Biomechanical study on cadaveric bones using physiological loading conditions to quantify interfragmentary movements in a tibial shaft fracture model fixed by intramedullary nailing. METHODS: Six fresh frozen human cadaveric tibiae were sequentially tested in axial, torsional, 4-point bending, and shear loading configurations. Tests were performed in intact specimens and osteotomized specimens equipped with interlocked intramedullary nails. The amount of clearance of the nail within the intramedullary canal was measured on computed tomography scans. Linear and angular deformations of the fragments were continuously measured in all directions to obtain the exact interfragmentary movements. RESULTS: The amount of movement at the site of the fracture was substantial. Especially shear and torsion resulted in gap movements of up to 10 mm. Movements in the transverse plane were significantly larger than axial movements for all loading conditions. For torsion and bending, a significant portion of the movement of the fracture gap resulted from the flexibility of the intramedullary nail; for compression and shear, the majority of the movement was related to the clearance of the nail within the bone. CONCLUSIONS: Clearance of the implant within the medullary canal, the flexibility of the implant itself, and the compliance of the implant (nail and locking screws) within the bone determine the extent of movement. The implant flexibility and the clearance are strongly dependent on the thickness of the intramedullary nail.

Cervical anterior transpedicular screw fixation (ATPS)--Part II. Accuracy of manual insertion and pull-out strength of ATPS.

Reconstruction after multilevel decompression of the cervical spine, especially in the weakened osteoporotic, neoplastic or infectious spine often requires circumferential stabilization and fusion. To avoid the additional posterior surgery in these cases while increasing rigidity of anterior-only screw-plate constructs, the authors introduce the concept of anterior transpedicular screw (ATPS) fixation. We demonstrated its morphological feasibility as well as its indications in a previous study in Part I of our project. Consequently, the objectives of the current study were to assess the ex vivo accuracy of placing ATPS into the cervical vertebra as well as the biomechanical performance of ATPS in comparison to traditional vertebral body screws (VBS) in terms of pull-out strength (POS). Twenty-three ATPS were inserted alternately to two screws into the pedicles and vertebral bodies, respectively, of six cadaveric specimens from C3-T1. For insertion of ATPS, a manual fluoroscopically assisted technique was used. Pre- and post insertional CT-scans were used to assess accuracy of ATPS insertion in the axial and sagittal planes. A newly designed grading system and accuracy score were used to delineate accuracy of ATPS insertion. Following insertion of screws, 23 ATPS and 22 VBS were subjected to pull-out testing (POT). The bone mineral density (BMD) of each specimen was assessed prior to POT. Statistical analysis showed that the incidence of correctly placed screws and non-critical pedicles breaches in axial plane was 78.3%, and 95.7% in sagittal plane. Hence, according to our definition of "critical" pedicle breach that exposes neurovascular structures at risk, 21.7% (n = 5) of all ATPS inserted showed a critical pedicle breach in axial plane. Notably, no critical pedicle perforation occurred at the C6 to T1 levels. Pull-out testing of ATPS and VBS revealed that pull-out resistance of ATPS was 2.5-fold that of VBS. Mean POS of 23 ATPS with a mean BMD of 0.566 g/cm(2) and a mean osseus screw purchase of 27.2 mm was 467.8 N. In comparison, POS of 22 VBS screws with a mean BMD of 0.533 g/cm(2) and a mean osseus screw purchase of 16.0 mm was 181.6 N. The difference in ultimate pull-out strength between the ATPS and VBS group was significant (p < 0.000001). Also, accuracy of ATPS placement in axial plane was shown to be significantly correlated with POS. In contrast, there was no correlation between screw-length, BMD, or level of insertion and the POS of ATPS or VBS. The study demonstrated that the use of ATPS might be a new technique worthy of further investigation. The use of ATPS shows the potential to increase construct rigidity in terms of screw-plate pull-out resistance. It might diminish construct failures during anterior-only reconstructions of the highly unstable decompressed cervical spine.