Robert Wendlandt

Biomechanical testing of a new plate system for the distal humerus compared to two well-established implants

PurposeA biomechanical study was performed to test the hypothesis that a new anatomically preformed, thinner, soft-tissue protecting plate system for distal humeral fractures (Tifix®-hybridplate [HP]) would show comparable results in the quasi-static and dynamic testings compared to two conventional implants: The 3.5-mm reconstruction plate (RP) providing primary stability with normal bone mineral density (BMD), and a multidirectional locking plate (Tifix®-plate [P]) which can be used with poor bone quality.MethodsThe Tifix®-HP was developed by the working group. The biomechanical testing was performed on a C2-fracture-model in 24 synthetic humeri. Three groups, each with eight bone-implant-constructs, were analysed in quasi-static and dynamic tests.ResultsThe quasi-static measurements showed that under extension loading both locking plates (Tifix®-P, Tifix®-HP) were significantly stiffer than the reconstruction plate, and that the Tifix®-HP had a significantly lower stiffness than the two other implants under flexion loading. In the dynamic tests the Tifix®-P allowed significantly less fracture motion compared to the Tifix®-HP and the reconstruction plate. In an osteopaenic bone model locking plates failed only under much higher dynamic force than the reconstruction plate. The reconstruction plate and the Tifix®-P always failed through screw loosening, whereas the newly developed Tifix®-HP showed screw loosening in only one third of cases.ConclusionThe hypothesis that the newly designed plate system showed comparable results in the quasi-static and dynamic tests compared to the conventional implants with a significantly lower implant volume and thickness was confirmed.

Improving stability of elastic stable intramedullary nailing in a transverse midshaft femur fracture model: biomechanical analysis of using end caps or a third nail

BackgroundElastic stable intramedullary nailing (ESIN) is accepted widely for treatment of diaphyseal femur fractures in children. However, complication rates of 10 to 50 % are described due to shortening or axial deviation, especially in older or heavier children. Biomechanical in vitro testing was performed to determine whether two modified osteosyntheses with end caps or a third nail could significantly improve the stability in comparison to classical elastic stable intramedullary nailing in a transverse femur fracture model.MethodsWe performed biomechanical testing in 24 synthetic adolescent femoral bone models (Sawbones®) with a transverse midshaft (diaphyseal) fracture. First, in all models, two nails were inserted in a C-shaped manner (2 × 3.5 mm steel nails, prebent), then eight osteosyntheses were modified by using end caps and another eight by adding a third nail from the antero-lateral (2.5-mm steel, not prebent). Testing was performed in four-point bending, torsion, and shifting under physiological 9° compression.ResultsThe third nail from the lateral showed a significant positive influence on the stiffness in all four-point bendings as well as in internal rotation comparing to the classical 2C configuration: mean values were significantly higher anterior-posterior (1.04 vs. 0.52 Nm/mm, p < 0.001), posterior-anterior (0.85 vs. 0.43 Nm/mm, p < 0.001), lateral-medial (1.26 vs. 0.70 Nm/mm, p < 0.001), and medial-lateral (1.16 vs. 0.76 Nm/mm, p < 0.001) and during internal rotation (0.16 vs. 0.11 Nm/°, p < 0.001). The modification with end caps did not improve the stiffness in any direction.ConclusionsThe configuration with a third nail provided a significantly higher stiffness than the classical 2C configuration as well as the modification with end caps in this biomechanical model. This supports the ongoing transfer of the additional third nail into clinical practice to reduce the axial deviation occurring in clinical practice.

Biomechanical testing of a novel osteosynthesis plate for the ulnar coronoid process.

Background The present study aimed to biomechanically evaluate a novel locking plate intended for osteosynthesis of coronoid fracture compared to mini L-plates and cannulated screws. Methods Biomechanical tests were performed on a fracture model in synthetic bones. Three groups, each with eight implant-bone-constructs, were analyzed in quasi-static and dynamic tests. Finally, samples were tested destructively for maximum strength. Results The mean (SD) highest stiffness was measured for the novel plate [693 (18) N/mm], followed by the mini L-plate [646 (37) N/mm] and the cannulated screws [249 (113) N/mm]. During the cycling testing of the novel plate and the mini L-plate, no failures occurred, although three of the eight samples of cannulated screws failed during the test. The mean (SD) maximum strength during the destructive testing was 1333 (234) N for the novel plate, 1338 (227) N for the mini-L-plate and 459 (56) N for the cannulated screws. No statistical differences were found during the destructive testing between the two plates (p = 0.999), although statistical differences were found between both plates and the cannulated screws (p = 0.000 each). Conclusions Osteosynthesis of the coronoid process using the novel plate is mechanically similar to the mini L-plate. Both plates were superior to osteosynthesis with cannulated screws.

Accuracy of a hexapod parallel robot kinematics based external fixator.

Different hexapod‐based external fixators are increasingly used to treat bone deformities and fractures. Accuracy has not been measured sufficiently for all models.

Additional Tension Screws Improve Stability in Elastic Stable Intramedullary Nailing: Biomechanical Analysis of a Femur Spiral Fracture Model

PURPOSE For pediatric femoral shaft fractures, elastic stable intramedullary nailing (ESIN) is an accepted method of treatment. But problems regarding stability with shortening or axial deviation are well known in complex fracture types and heavier children. Biomechanical in vitro testing was performed to determine whether two modified osteosyntheses with an additional tension screw fixation or screw fixation alone without nails could significantly improve the stability in comparison to classical ESIN. METHODS A total of 24 synthetic adolescent-sized femoral bone models (Sawbones, 4th generation; Vashon, Washington, United States) with an identical spiral fracture (length 100 mm) were used. All grafts underwent retrograde fixation with two C-shaped steel nails (2C). Of the 24, 8 osteosyntheses were supported by one additional tension screw (2C1S) and another 8 by two screws (2S) in which the intramedullary nails were removed before testing. Each configuration underwent biomechanical testing in 4-point bending, external rotation (ER) and internal rotation (IR). Furthermore, the modifications were tested in axial physiological 9 degrees position for shifting and dynamic compression as well as dynamic load. RESULTS Both screw configurations (2C1S and 2S) demonstrated a significantly higher stability in comparison to the 2C configuration in 4-point bending (anterior-posterior, 0.95 Nm/mm [2C] < 8.41 Nm/mm [2C1S] and 15.12 Nm/mm [2S]; posterior-anterior, 8.55 Nm/mm [2C] < 12.65 Nm/mm [2C1S] and 17.54 Nm/mm [2S]; latero-medial, 1.17 Nm/mm [2C] < 5.53 Nm/mm [2C1S] and 9.15 Nm/mm [2S]; medio-lateral, 1.74 Nm/mm [2C] < 9.69 Nm/mm [2C1S] and 12.20 Nm [2S]; all p < 0.001) and during torsion (ER, 0.61 Nm/degree [2C] < 4.10 Nm/degree [2C1S] and 9.29 Nm/degree [2S]; IR, 0.18 Nm/degree [2C] < 6.17 Nm/degree [2C1S] and 10.61 Nm/degree [2S]; all p < 0.001]. The shifting in compression in 9 degrees position was only slightly influenced. The comparison of 2S versus 2C1S showed more stability for 2S than 2C1S in all testing, except the axial 9 degrees compression tests for shifting. In contrast to the 2C configuration, both modifications (2C1S and 2S) turned out to be stable in dynamic 9 degrees axial compression with a force of 100 up to 1,000 N at 2.5 Hz in 250,000 load cycles. CONCLUSIONS In this in vitro adolescence femur spiral fracture model, the stability of ESIN could be significantly improved by two modifications with additional tension screws. If transferred in clinical practice, these modifications might offer earlier weight bearing and less problems of shortening or axial deviation.

A biomechanical analysis of plate fixation using unicortical and bicortical screws in transverse metacarpal fracture models subjected to 4-point bending and dynamical bending test

Abstract In the published literature there are controversial data to the biomechanical stability of monocortical comparing to the bicortical fixation of metacarpal fractures. The aim of this study was to compare the biomechanical stability of monocortical and bicortical locking osteosynthesis in quasi-static and dynamic 4-point bending tests of composite third metacarpal bone (4th Gen third metacarpal, Sawbones, Malmö, Sweden) fixed with 7-hole locking plate (XXS System, Biotech-Ortho, Wright, Memphis, TN). The tests to determine quasi-static yield and bending strength as well as fatigue strength were conducted in 4 groups of 10 samples after creating standardized mid-shaft transverse osteotomies using a diamont belt grinder (0.3 mm saw blade). The force applied was the dorsal apex loading, similar to the forces applied to metacarpals during normal finger flexion and extension. In the quasi-static testing, no plate breakage was observed in each group. All metacarpals broke at their thinnest part. The average bending strength of the bicortical samples (10.54 ± 0.998 Nm) was significantly higher comparing to the monocortical samples (8.57 ± 0.894 Nm) (P < .001). In the dynamic loading test, all constructs (8 monocortical samples and 7 bicortical) that failed broke at the osteotomy site and the average fatigue strength did not differ in both groups. Consequently, a unicortical plating method may provide adequate strength and stability to metacarpal fractures based on the results of the cyclical loading representative of in vivo loading.

Bone plates for osteosynthesis - a systematic review of test methods and parameters for biomechanical testing.

Abstract Bone plates for osteosynthesis are subject to biomechanical testing for safety and regulatory purposes. International standards applicable for those devices are designed for bone plates used in the surgical fixation of the skeletal system but not necessarily for all device variants available. We intend to summarize the test methods and parameters presented in the literature to evaluate bone plates in a clinical environment, especially for modern anatomically shaped implants. We conducted a systematic review on published biomechanical studies for lower and upper extremities (clavicle, humerus, ulna, radius, metacarpal, femur, tibia, fibula, metatarsal). The search process led to the identification of 159 relevant articles containing 330 individual tests, which were analyzed concerning various test criteria including test methods and parameters per bone segment for static and dynamic loading tests, as well as number of cycles, chosen bone model and outcome variables. The biomechanical literature for bone plates is diverse, inconsistent and heterogeneous. Test methods are not commonly applied per bone plate location and test parameters are not uniformly specified and displayed. They vary in particular for bending and torsion tests as well as for the number of loading cycles for dynamic testing. Outcome variables are not commonly applied nor defined. Consequently this paper is the first in a planned chronological series of three to identify the need (this publication), to develop a systematic procedural approach (2. publication) and to apply the process exemplary on a bone plate sample (3. publication).

Bone plate-screw constructs for osteosynthesis – recommendations for standardized mechanical torsion and bending tests

Abstract This paper follows up on a recent systematic review of test methods and parameters for biomechanical testing of bone plates and it is the first study that contains recommendations for standardized mechanical testing of bone plate-screw constructs for osteosynthesis. Following the testing philosophy of ASTM F382 and ISO 9585, we have developed standardized quasi-static and dynamic testing methods for straight linear and anatomically shaped plates, including locked type and conventional systems. The test specification comprises torsion and bending tests along the implant axis and therefore modifies and extends the methods proposed by ASTM F382. We present specific test setups in order to determine product-specific characteristics of the mechanical construct, consisting of the bone plate with corresponding screws (such as construct stiffness, yield strength, ultimate strength and fatigue properties) under the condition that it is rigidly fixed to “healthy bone”. We also address specific testing requirements that are important for the purpose of standardization, such as the positioning of the construct for testing or the number of screws in the diaphysis and metaphysis. Finally, we define the outcome parameters and associated failure criteria related to quasi-static and dynamic testing for comparative purposes. This paper does not intend to replace biomechanical testing of those devices under physiological loading conditions.

Biomechanical evaluation of novel ultrasound-activated bioresorbable pins for the treatment of osteochondral fractures compared to established methods.

Abstract Background: Osteochondral injuries often lead to osteoarthritis of the affected joint. All established systems for refixation of osteochondral defects show certain disadvantages. To address the problem of reduced stability in resorbable implants, ultrasound-activated pins were developed. By ultrasound-activated melting of the tip of these implants, a more secure anchoring is assumed. Materials and methods: The aim of the study was to investigate if ultrasound-activated pins can provide secure fixation of osteochondral fragments compared to screws and conventional resorbable pins. In a biomechanical laboratory setting, osteochondral fragments of the medial femoral condyle of sheep were refixated with ultrasound-activated pins [US fused poly(L-lactide-co-D,L-lactide) (PLDLLA) pins], polydioxanone (PDA) pins and conventional titanium screws. Anchoring forces of the different fixation methods were examined, registered and compared concerning shear force and tensile force. Results: Concerning the pull out test, the US fused PLDLLA pins and titanium screws (~122 N and ~203 N) showed comparable good results, while the PDA pins showed significantly lower anchoring forces (~18 N). Examination of shear forces showed a significantly higher anchoring of the screws (~248 N) than the US fused PLDLLA pins (~218 N). Nevertheless, the US fused PLDLLA pins could significantly outperform the PDA pins (~68 N) concerning shear forces. Conclusion: The US fused PLDLLA pins demonstrated a comparable anchorage to the fixation with screws, but were free from the disadvantages of metal implants, i.e. the need for implant removal. The PDA pin application showed inferior biomechanical properties.