Implant Material, Type of Fixation at the Shaft, and Position of Plate Modify Biomechanics of Distal Femur Plate Osteosynthesis.

OBJECTIVES: To investigate whether (1) the type of fixation at the shaft (hybrid vs. locking), (2) the position of the plate (offset vs. contact) and (3) the implant material has a significant effect on (a) construct stiffness and (b) fatigue life in a distal femur extraarticular comminuted fracture model using the same design of distal femur periarticular locking plate. METHODS: An extraarticular severely comminuted distal femoral fracture pattern (OTA/AO 33-A3) was simulated using artificial bone substitutes. Ten-hole distal lateral femur locking plates were used for fixation per the recommended surgical technique. At the distal metaphyseal fragment, all possible locking screws were placed. For the proximal diaphyseal fragment, different types of screws were used to create 4 different fixation constructs: (1) stainless steel hybrid (SSH), (2) stainless steel locked (SSL), (3) titanium locked (TiL), and (4) stainless steel locked with 5-mm offset at the diaphysis (SSLO). Six specimens of each construct configuration were tested. First, each specimen was nondestructively loaded axially to determine the stiffness. Then, each specimen was cyclically loaded with increasing load levels until failure. RESULTS: Construct Stiffness: The fixation construct with a stainless steel plate and hybrid fixation (SSH) had the highest stiffness followed by the construct with a stainless steel plate and locking screws (SSL) and were not statistically different from each other. Offset placement (SSLO) and using a titanium implant (TiL) significantly reduced construct stiffness. Fatigue Failure: The stainless steel with hybrid fixation group (SSH) withstood the most number of cycles to failure and higher loads, followed by the stainless steel plate and locking screw group (SSL), stainless steel plate with locking screws and offset group (SSLO), and the titanium plate and locking screws group (TiL) consecutively. Offset placement (SSLO) as well as using a titanium implant (TiL) reduced cycles to failure. CONCLUSIONS: Using the same plate design, the study showed that implant material, screw type, and position of the plate affect the construct stiffness and fatigue life of the fixation construct. With this knowledge, the surgeon can decide the optimal construct based on a given fracture pattern, bone strength, and reduction quality.

The effect of contouring on fatigue resistance of three types of fracture fixation plates.

BACKGROUND: Metallic reconstruction plates used for fracture stabilization typically require intraoperative contouring for patient-specific anatomical fit. Despite this, characterization of plate mechanical properties after contouring has previously been limited. The objective of this study was to assess whether contouring affects fatigue resistance for three types of Stryker seven-hole stainless steel (SS) 316LVM fracture fixation plates. The hypothesis was that for each plate type, more contouring repetitions would result in lower fatigue resistance. METHODS: Plates were contoured using a bench-top plate bender to ±20° either 0×, 3×, 6×, or 9× (n = 5 per group) and tested in the straight configuration. Cyclic four-point bending was applied in an incremental stepwise staircase approach (one step = 100,000 cycles, 10 Hz) until failure (defined as brittle fracture or plastic deformation of 10° permanent bend). Moment-cycle product (MCP) was computed as the summation of maximum moment × number of cycles and used as the primary measure of fatigue resistance. RESULTS: No significant differences in fatigue resistance were detected between contouring groups for Basic Fragment Set (BFS) Reconstruction Plates. Significantly lower fatigue resistance was measured for 9× contoured Matta Pelvic System (MPS) Straight Plates compared to 0× contoured plates (p = 0.023). MPS Flex Plates contoured 3× had greater fatigue resistance than 0× contoured (p = 0.031) and 9× contoured plates (p = 0.032). CONCLUSIONS: This work provides fatigue resistance-based evidence that clinicians should avoid high repetitions of contouring for MPS Straight Plates. Meanwhile, BFS Reconstruction Plates and MPS Flex Plates are not negatively affected by contouring. These results allow for improved intraoperative decisions about using or discarding plates after multiple contouring repetitions.

Comminuted olecranon fracture fixation with pre-contoured plate: Comparison of composite and cadaver bones.

AIM: To determine whether use of a precontoured olecranon plate provides adequate fixation to withstand supraphysiologic force in a comminuted olecranon fracture model. METHODS: Five samples of fourth generation composite bones and five samples of fresh frozen human cadaveric left ulnae were utilized for this study. The cadaveric specimens underwent dual-energy X-ray absorptiometry (DEXA) scanning to quantify the bone quality. The composite and cadaveric bones were prepared by creating a comminuted olecranon fracture and fixed with a pre-contoured olecranon plate with locking screws. Construct stiffness and failure load were measured by subjecting specimens to cantilever bending moments until failure. Fracture site motion was measured with differential variable resistance transducer spanning the fracture. Statistical analysis was performed with two-tailed Mann-Whitney-U test with Monte Carlo Exact test. RESULTS: There was a significant difference in fixation stiffness and strength between the composite bones and human cadaver bones. Failure modes differed in cadaveric and composite specimens. The load to failure for the composite bones (n = 5) and human cadaver bones (n = 5) specimens were 10.67 nm (range 9.40-11.91 nm) and 13.05 nm (range 12.59-15.38 nm) respectively. This difference was statistically significant (P ˂ 0.007, 97% power). Median stiffness for composite bones and human cadaver bones specimens were 5.69 nm/mm (range 4.69-6.80 nm/mm) and 7.55 nm/mm (range 6.31-7.72 nm/mm). There was a significant difference for stiffness (P ˂ 0.033, 79% power) between composite bones and cadaveric bones. No correlation was found between the DEXA results and stiffness. All cadaveric specimens withstood the physiologic load anticipated postoperatively. Catastrophic failure occurred in all composite specimens. All failures resulted from composite bone failure at the distal screw site and not hardware failure. There were no catastrophic fracture failures in the cadaveric specimens. Failure of 4/5 cadaveric specimens was defined when a fracture gap of 2 mm was observed, but 1/5 cadaveric specimens failed due to a failure of the triceps mechanism. All failures occurred at forces greater than that expected in postoperative period prior to healing. CONCLUSION: The pre-contoured olecranon plate provides adequate fixation to withstand physiologic force in a composite bone and cadaveric comminuted olecranon fracture model.

Biomechanical comparison of a lateral polyaxial locking plate with a posterolateral polyaxial locking plate applied to the distal fibula.

BACKGROUND: Polyaxial locking plates are becoming popular for the fixation of distal fibula fractures. This study establishes how construct stiffness and plate loosening, measured as range of motion, differs between lateral and posterolateral plate location. METHODS: Seven matched pairs of cadaver fibulae were osteotomized in standardized fashion to produce a Weber type B distal fibula fracture. The fragments were fixated with an interfragmentary lag screw and polyaxial locking plates, with one fibula in each pair receiving a posterolateral anti-glide-plate, and the other a lateral neutralization-plate. In a biomechanical test, the bending and torsional stiffnesses of the constructs and the ranges of motion (ROM) were measured and subjected to a paired comparison. RESULTS: The laterally plated group had a higher median (interquartile range) bending stiffness (29.2 (19.7) N/mm) and a smaller range of motion (2.06 (1.99) mm) than the posterolaterally plated group (14.6 (20.6) N/mm, and 4.11 (3.28) mm, respectively); however, the results were not statistically significant (pbending=0.314; pROM=0.325). Similarly, the torsional stiffness did not differ significantly between the two groups (laterally plated: 426 (259) Nmm/°; posterolaterally plated: 248 (399) Nmm/°; ptorsion=0.900). The range of motion measurements between the two groups under torsional loading were also statistically insignificant (laterally plated: 8.88 (6.30) mm; posterolaterally plated: 15.34 (12.64) mm; pROM=0.900). CONCLUSION: In biomechanical cadaver-model tests of Weber type B fracture fixation with polyaxial locking plates, laterally plated constructs and posterolaterally plated constructs performed without significantly difference. Therefore, other considerations, such as access morbidity, associated injuries, patient anatomy, or surgeon's preference, may guide the choice of plating pattern. Further clinical studies will be needed for the establishment of definitive recommendations. CLINICAL RELEVANCE: Information on the behavior of polyaxial locking plates is relevant to surgeons performing internal fixation of distal fibula fractures.

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.

Evidence Based Development of a Novel Lateral Fibula Plate (VariAx Fibula) Using a Real CT Bone Data Based Optimization Process During Device Development.

Development of novel implants in orthopaedic trauma surgery is based on limited datasets of cadaver trials or artificial bone models. A method has been developed whereby implants can be constructed in an evidence based method founded on a large anatomic database consisting of more than 2.000 datasets of bones extracted from CT scans. The aim of this study was the development and clinical application of an anatomically pre-contoured plate for the treatment of distal fibular fractures based on the anatomical database.48 Caucasian and Asian bone models (left and right) from the database were used for the preliminary optimization process and validation of the fibula plate. The implant was constructed to fit bilaterally in a lateral position of the fibula. Then a biomechanical comparison of the designed implant to the current gold standard in the treatment of distal fibular fractures (locking 1/3 tubular plate) was conducted. Finally, a clinical surveillance study to evaluate the grade of implant fit achieved was performed. The results showed that with a virtual anatomic database it was possible to design a fibula plate with an optimized fit for a large proportion of the population. Biomechanical testing showed the novel fibula plate to be superior to 1/3 tubular plates in 4-point bending tests. The clinical application showed a very high degree of primary implant fit. Only in a small minority of cases further intra-operative implant bending was necessary. Therefore, the goal to develop an implant for the treatment of distal fibular fractures based on the evidence of a large anatomical database could be attained. Biomechanical testing showed good results regarding the stability and the clinical application confirmed the high grade of anatomical fit.

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.