Pre-clinical testing of hip endoprostheses is a mandatory requirement before clinical release. Inadequate loading conditions may lead to lower elastic and plastic interface movements than those occurring post-operatively in vivo.This study investigated the influence of patient activity on the primary stability of cementless prostheses with a special emphasis on active simulation of muscle forces. A loading setup, based on validated musculo-skeletal analyses, was used to generate the hip contact force during walking and stair climbing by transmitting muscle forces through the femur. In addition, a loading configuration which only generated the hip contact force occurring during stair climbing at the prosthesis head was simulated. CLS prostheses were implanted in 18 composite femora and subjected to cyclical loading. The relative micro-movements at the bone prosthesis interface were determined and appeared to be extremely sensitive to the specific patient activity. Compared to walking, stair climbing generated higher micro-movements, with pronounced axial and rotational components. Stair climbing with the femur loaded by the resultant hip contact force only exhibited a characteristic valgus tilt of the stem with significantly lower interface micro-movements than under active simulation of muscle forces. The analyses suggest that stair climbing induced the highest mechanical instability at the bone prosthesis interface, a level which may compromise the necessary osseointegration process. Active simulation of muscle forces considerably affects the primary stability of cementless hip endoprostheses. Pre-clinical in vitro tests should therefore simulate stair climbing and include muscle activity in the assessment of initial implant stability, otherwise micro-movements may be underestimated and the primary stability overestimated. (c) 2004 Elsevier Ltd. All rights reserved.

The stability of joint endoprostheses depends on the loading conditions to which the implant-bone complex is exposed. Due to a lack of appropriate muscle force data, less complex loading conditions tend to be considered in vitro. The goal of this study was to develop a load profile that better simulates the in vivo loading conditions of a “typical” total hip replacement patient and considers the interdependence of muscle and joint forces. The development of the load profile was based on a computer model of the lower extremities that has been validated against in vivo data. This model was simplified by grouping functionally similar hip muscles. Muscle and joint contact forces were computed for an average data set of up to four patients throughout walking and stair climbing. The calculated hip contact forces were compared to the average of the in vivo measured forces. The final derived load profile included the forces of up to four muscles at the instances of maximum in vivo hip joint loading during both walking and stair climbing. The hip contact forces differed by less than 10% from the peak in vivo value for a “typical” patient. The derived load profile presented here is the first that is based on validated musculoskeletal analyses and seems achievable in an in vitro test set-up. It should therefore form the basis for further standardisation of pre-clinical testing by providing a more realistic approximation of physiological loading conditions.

Fracture healing is influenced by fixation stability and experimental evidence suggests that the initial mechanical conditions may determine the healing outcome. We hypothesised that mechanical conditions influence not only the healing outcome, but also the early phase of fracture healing. Additionally, it was hypothesised that decreased fixation stability characterised by an increased shear interfragmentary movement results in a delay in healing. Sixty-four sheep underwent a mid-shaft tibial osteotomy which was treated with either a rigid or a semi-rigid external fixator. Animals were sacrificed at 2, 3, 6 and 9 weeks postoperatively and the fracture callus was analysed using radiological, biomechanical and histological techniques. The tibia treated with semi-rigid fixation showed inferior callus stiffness and quality after 6 weeks. At 9 weeks, the calluses were no longer distinguishable in their mechanical competence. The calluses at 9 weeks produced under rigid fixation were smaller and consisted of a reduced fibrous tissue component. These results demonstrate that the callus formation over the course of healing differed both morphologically and in the rate of development. In this study, we provide evidence that the course of healing is influenced by the initial fixation stability. The semi-rigid fixator did not result in delayed healing, but a less optimal healing path was taken. An upper limit of stability required for successful healing remains unknown, however a limit by which healing is less optimal has been determined.

Primary stability and in consequence osteointegration are commonly related to the stem anchorage but also to the complex musculoskeletal loading of the hip region. This study investigated the influence of metaphyseal and meta-diaphyseal anchorage on the primary stability of cementless stems under physiological-like loading in vitro. Metaphyseal and meta-diaphyseal anchoring stems (n=6 each) were implanted into composite femora. Musculoskeletal loads, validated by in vivo data (peak joint force 2348 N), were applied using a mechanical set-up. Interface movements were recorded by seven displacement transducers and primary stability was compared. Both stems exhibited similar movement patterns and principally moved distally with a retroversional twist. Although elastic movements were comparable, the metaphyseal stem exhibited higher plastic deformations than the meta-diaphyseal stem, particularly for the metaphyseal, medio-lateral and antero-posterior components. Under physiological-like loading, the metaphyseal stem allowed higher interface movements and tended to initially migrate faster than the meta-diaphyseal stem and then stabilized. Elastic movements were comparable and seemed to be less influenced by the anchoring concept than by the mechanical properties of the bone. The analyses emphasize the importance of metaphyseal bone in proximal anchorage and the necessity of an accurate canal preparation to prevent excessive initial migration.

Locked intramedullary nailing and external fixation are alternatives for the stabilization of tibial shaft fractures. The goal of this study was to determine to what extent the mechanical conditions at the fracture site influence the healing process after unreamed tibial nailing compared to external fixation. A standardized tibial diastasis was stabilized with either a locked unreamed tibial nail or a monolateral fixator in a sheep model. Interfragmentary movements and ground reaction parameters were monitored in vivo throughout the healing period. After sacrifice, the tibiae were examined mechanically and histologically. Bending angles and axial torsion at the fracture site were larger in the nail group within the first five weeks post-operatively. Unlike the fixator group, the operated limb in the nail group did not return to full weight bearing during the treatment period. Mechanical and histomorphometrical observations showed significantly inferior bone healing in the nail group compared to the fixator group. In this study, unreamed nailing of a tibial diastasis did not provide rotational stability of the osteosynthesis and resulted in a significant delay in bone healing.

BACKGROUND:The objective of this study was to determine the in vitro characteristics of the clinically used and newly developed implants for the stabilization of proximal humeral fractures under static and cyclic loading. The goal was to optimize implant stiffness for fracture stabilization even in weak bone stock.METHODS:In a laboratory study using 35 fresh human humeri, the specimens were randomized into 5 groups, which included the clinically used humerus T-plate (HTP), the cross-screw osteosynthesis (CSO), the unreamed proximal humerus nail with spiral blade (UHN), the recently developed Synclaw Proximal Humerus Nail (Synclaw PHN) and the angle-stable Locking Compression Plate Proximal Humerus (LCP-PH). The implant stiffness was determined for three clinically relevant load cases: axial compression, torsion and varus bending. In addition, a cyclic varus-bending test was performed to determine the implant properties under cyclic loading.RESULTS:In contrast to a rather elastic and minimally invasive implant(LCP-PH), the conventionally designed ones (Synclaw PHN, CSO, HTP, UHN) showed rather high stiffness values under static loading. In cyclic loading, a strong decrease in stiffness ( p<0.05) was found for the rigid implants HTP and UHN. In comparison with the other implants, only the elastic implant (LCP-PH) showed a significantly lower load reduction in a weak bone stock (17+/-6.2%).CONCLUSION:The high initial stiffness of rigid implants led to an early loosening and failure of the implant-bone interface under cyclic loading. Implants with low stiffness and elastic characteristics, however, appear to minimize the peak stresses at the bone-implant interface, making them particularly suitable for fracture fixation in osteoporotic bone.

Interfragmentary movements affect the quality and quantity of callus formation. The mounting plane of monolateral external fixators may give direction to those movements. Therefore, the aim of this study was to determine the influence of the fixator mounting plane on the process of fracture healing. Identically configured fixators were mounted either medially or anteromedially on the tibiae of sheep. Interfragmentary movements and ground reaction forces were evaluated in vivo during a nine week period. Histomorphological and biomechanical parameters described the bone healing processes. Changing only the mounting plane led to a modification of interfragmentary movements in the initial healing phase. The difference in interfragmentary movements between the groups was only significant during the first post-operative period. However, these initial differences in mechanical conditions influenced callus tissue formation significantly. The group with the anteromedially mounted fixator, initially showing significantly more interfragmentary movements, ended up with a significantly smaller callus diameter and a significantly higher callus stiffness as a result of advanced fracture healing. This demonstrates that the initial phase of healing is sensitive to mechanical conditions and influences the course of healing. Therefore, initial mechanical stability of an osteosynthesis should be considered an important factor in clinical fracture treatment.

Objectives. The goal was to design a method which would permit in assessment of the suitability of a newly developed implant under physiological-like loading conditions. Information obtained from Such an analysis is expected to delineate more clearly the indications for a new device prior to clinical utilization.Design. In vitro mechanical stiffness testing and finite element analysis.Methods. From in vitro testing of proximal tibiae with defects, the stiffness of an internal stabilization system was determined. Using it finite element model, the loading of both the implant and bone was analyzed including all muscle forces. The variation in implant loading and interfragmentary strain for different defect locations was also investigated.Results. Conventional stiffness testing demonstrated the comparability of the experimental findings with the finite element predictions. Under physiological-like loading the implant experienced high bending and von Mises stresses it defects in the region of the shaft were stabilized. A short working length increased implant loading Lip to the yield strength of the material.Conclusions. The finite element analysis illustrated the appropriateness of this new device for proximal defects of the tibia, but the implant should be used hesitantly in fractures or defects extending into the diaphyseal region of the bone.

Complex ligamenteous lesions often require a partial or total arthrodesis of the carpal joint. Different methods with varying results are described in the literature. In an experimental study the stiffness of partial arthrodesed carpal joints were tested biomechanically comparing the t-plate and twin plate mounting. Due to the superior stiffness of the twin plate a clinical prospective study followed. Between 1997 and 2001 the patients presented at the Clinic for Small Animals of the Free University Berlin for partial arthrodesis of the carpal joint were surgically treated alternating with a t-plate respectively a twin plate and the results were evaluated. Also clinically the twin plate showed advantages in comparison to the t-plate.

Relative movement of bone fragments affects healing processes. In vivo data exist for patients with reduced transverse fractures only. The gap movements that occur under more complex conditions such as in tibial osteotomies, however, are unknown. The goal of this study was to determine the initial gap movements in tibial correction osteotomies, to monitor movements during the early healing period, and to determine the suitability of initial fixation stability in relation to daily activities. The interfragmentary movements were measured in six patients with correction osteotomies stabilized by Ilizarov ring fixator constructs until union or until conversion to internal fixation. Consolidation was determined by clinical evaluation and standard radiographic techniques. Co-contraction led to gap movements comparable with level walking or standing. Shear generally exceeded axial compression. Although ground reactions and fixation stiffness were comparable with those reported for reduced fractures, movement magnitudes generally were larger than 2 mm. The shear movement component reflected the nature of the mechanical conditions at the bone gap. In a direct comparison with data from animal experiments, the local mechanical environment at the bone gap seemed unstable rather than overly stable. The method introduced in this study opens the perspective of adjusting osteosynthesis stability to the specific needs of each patient.

Different fixation systems are used for fracture and defect treatment. A prerequisite for complication free healing is sufficient mechanical stability of the osteosynthesis. In vitro investigations offer the possibility of both analysing and assessing the pre-clinical fixation stability. Due to the complex loading environment in vivo, stiffness analysis should include a complete determination of the stiffness under standardised conditions.Based on a mathematical procedure to calculate the 3-D stiffness, a mechanical testing device for the 3-D loading of fixation systems was designed and integrated in the existing test set-up. The set-up consisted of a material testing machine to produce the necessary loads and an optical measurement device to detect the resulting inter-fragmentary movements. To validate the testing device, the 3-D stiffness matrices of different Ilizarov fixator configurations were determined and compared.The good reproducibility of the test was reflected in the small intra-individual variability of the stiffness components. A distinct direction dependence of the fixator stiffness was observed. Increasing the number of rings led to a stiffness increase of up to 50%, especially in bending. The presented testing device allows a complete standardised determination of the stiffness of different fixation systems. It considers the direction dependence of the stiffness and creates a prerequisite for a more direct implant comparison.

Zusammenfassung Mit Hilfe eines mechanischen Testverfahrens wurden nach Variation ausgewählter Gestaltparameter klinisch eingesetzte Fixateurkonfigurationen in vitro untersucht. Zusätzlich wurde der Einfluss der passiven Weichteile an humanen Präparaten ermittelt. Eine Erhöhung der Anzahl der Schanz-Schrauben bzw. der Kirschner-Drähte bewirkte eine vergleichbare Steigerung der Steifigkeit wie eine Erhöhung des Durchmessers der Schrauben bzw. Drähte. Wo klinisch zulässig, sind daher größere Durchmesser anstelle einer höheren Anzahl der Schrauben bzw. Drähte zu empfehlen. Eine Reduzierung des Ringdurchmessers führte zu einer Steifigkeitszunahme. Bei Verwendung von diaphysären Transportspindeln nahm allein die Axialsteifigkeit ab. Wie erwartet, verringerten Titandrähte im Vergleich zu CoCr-Drähten fast alle Steifigkeitskomponenten. Nach gegenseitigem Verspannen der äußeren Ringebenen nahm die Gesamtsteifigkeit ab. Ein asymmetrisches Vorspannen der Kirschner-Drähte bewirkte einen Spannungsabfall im benachbarten Draht. Nach Entfernen des Weichteilmantels sank die gesamte Steifigkeit der Fixation im gleichen Ausmaß wie bei einem Defekt der Fibula. Die Studie zeigt die Zusammenhänge zwischen Gestaltparametern, passivem Weichteilmantel sowie Fixationssteifigkeit und gibt Richtlinien für die Fixateurgestaltung.

Using a mechanical testing procedure, various fixator constructs were tested in vitro. In addition, the influence of the passive soft tissue structures on the fixation stiffness was determined. An increased number of Schanz' screws or Kirschner wires led to a comparable increase in stiffness than that observed with an increasing screw or wire diameter. In consequence, larger diameters should be preferred over an additional screw or wire where clinically applicable. With diaphyseal telescoping rods only the axial stiffness decreased. As expected, large ring diameters as well as titanium wires reduced stiffness components. Bracing the outer rings caused a reduction of the overall stiffness. Asymmetric pre-tensioning of the K-wires resulted in a significant reduction of tension in the neighboring wire. Removal of the soft tissues reduced stiffness to a similar extend as experienced in a fibula defect situation. The study demonstrates the correlation between design parameters, passive soft tissues and fixation stiffness and presents guidelines for an optimized fixator design.