Development and testing of a new self-locking intramedullary nail system: testing of handling aspects and mechanical properties.

A distal interlocking system has been developed which is easy to use, carries out an aligning effect on the distal fracture fragment, reduces the exposure to radiation for the surgeon and the patient, and allows for a decrease in operating time. The goal of this study was to develop and test the handling and mechanical properties of two prototype nails in comparison to a conventional interlocking nail concept (Unreamed Femoral Nail system). It was shown that the prototype designs represent an improvement over this system. Both designs were easy to use. The prototype with the asymmetrically offset interlocking bolts exhibited an exemplary aligning effect on the distal fracture fragment. Both designs showed mechanical stability comparable or superior to that of the standard contralateral control in four-point-bending and axial compression. Given the handling advantages afforded by the new self-locking intramedullary implant system, it would be expected that use of this system would reduce exposure to radiation for the surgeon as well as the patient and allow for a decrease in operating time. This new development may be of particular interest for clinics without access to fluoroscopes in the operating theatre (e.g. in the Third World).

An ex vivo model to study transport processes and fluid flow in loaded bone.

Load-induced fluid flow has been postulated to provide a mechanism for the transmission of mechanical signals (e.g. via shear stresses, enhancement of molecular transport, and/or electrical effects) and the subsequent elicitation of a functional adaptation response (e.g. modeling, remodeling, homeostasis) in bone. Although indirect evidence for such fluid flow phenomena can be found in the literature pertaining to strain generated potentials, actual measurement of fluid displacements in cortical bone is inherently difficult. This problem motivated us to develop and introduce an ex vivo perfusion model for the study of transport processes and fluid flow within bone under controlled mechanical loading conditions. To this end, a closed-loop system of perfusion was established in the explanted forelimb of the adult Swiss alpine sheep. Immediately prior to mechanical loading, a bolus of tracer was introduced intraarterially into the system. Thereafter, the forelimb of the left or right side (randomized) was loaded cyclically, via Schanz screws inserted through the metaphyses, producing a peak compressive strain of 0.2% at the middiaphysis of the anterior metacarpal cortex. In paired experiments with perfusion times totalling 2, 4, 8 and 16 min, the concentration of tracer measured at the middiaphysis of the cortex in cross section was significantly higher in the loaded bone than in the unloaded contralateral control. Fluorometric measurements of procion red concentration in the anterior aspect alone showed an enhancement in transport at early stages of loading (8 cycles, 2 min) but no effect in transport after higher number of cycles or increased perfusion times, respectively. This reflects both the small size of the molecular tracer, which would be expected to be transported rapidly by way of diffusive mechanisms alone, as well as the loading mode to which the anterior aspect was exposed. Thus, using our new model it could be shown that load-induced fluid flow represents a powerful mechanism to enhance molecular transport within the lacunocanalicular system of compact bone tissue. Based on these as well as previous studies, it appears that the degree of this effect is dependent on tracer size as well as the mechanical loading mode to which a given area of tissue is exposed.

A novel ex vivo model for investigation of fluid displacements in bone after endoprosthesis implantation.

Tissue perfusion and mass transport in the vicinity of implant surfaces prior to integration or bonding may play a crucial role in modulating cellular activities associated with bone remodeling, in particular, at early stages of the integration process. Furthermore, fluid displacements have been postulated to transduct mechanical stress signals to bone cells via loading-dependent flow of interstitial fluid through the lacunocanalicular network of bone. Thus, an understanding and new possibilities for influencing these processes may be of great importance for implant success. An ex vivo model was developed and validated for investigation of fluid displacements in bone after endoprosthesis implantation. This model serves to explicate the effects of surgical intervention as well as mechanical loading of the implant-bone construct on load-induced fluid flow in the vicinity of the implant. Using this model, we intend to quantify perfusion and extravascular flow dynamics in the vicinity of implants and define optimal conditions for enhancing molecular transport of osteotropic agents from the implant surface to apposing bone as well as from the blood supply to the implant surface. Furthermore, the elucidation of main transport pathways may help in understanding the distribution of wear particles in bone surrounding implant, a process which has been postulated to cause osteolysis and implant loosening.

Experimental elucidation of mechanical load-induced fluid flow and its potential role in bone metabolism and functional adaptation.

Several researchers have developed theories implicating some manifestation of mechanical forces such as stress, strain, and strain energy density for the initiation of cellular processes associated with functional adaptation. The mechanisms underlying dynamic bone growth and repair in response to mechanical stimuli, however, are not fully understood. Load-induced fluid flow has been postulated to provide a mechanism for the transmission of mechanical signals (eg, via shear stresses, enhancement of molecular transport, or electrical effects) and the subsequent elicitation of a functional adaptation response in bone. Although indirect evidence for such fluid flow phenomena can be found in the literature pertaining to strain-generated potentials, experimental studies are inherently difficult. This motivated the authors to develop theoretical as well as ex vivo, in vitro, and in vivo experimental methods for the study of transport processes and fluid flow within bone under well-controlled mechanical loading conditions. By introducing tracer substances such as disulphine blue, procion red, and microperoxidase into the experimental system, transport and fluid flow could be visualized at tissue, cellular, and subcellular levels, respectively. Based on these studies, it could be shown that load-induced fluid flow represents a powerful mechanism to enhance molecular transport within compact bone tissue. Furthermore, the distribution of transport-elucidating tracers is a function of mechanical loading parameters as well as the location within the cross-section of the bone cortex.

In vivo tracer transport through the lacunocanalicular system of rat bone in an environment devoid of mechanical loading.

Although diffusion has been shown to be the major contributing mechanism for molecular transport in the extravascular spaces of organs and soft tissues, it is unlikely that diffusion alone can account for molecular transport in the porous, yet relatively impermeable matrix of bone. Rather, it has been proposed that fluid flow induced by the deformations that bone is subjected to during daily activities may promote molecular transport through convective mixing of fluids or enhancement of molecular transport from the capillaries to the outermost osteocytes within a given osteon. As the relative contribution of diffusive and convective transport in the bone matrix has not yet been elucidated, we conducted experiments to study the primary role of diffusion for molecular transport within bone and to establish a baseline for fluid transport whereby mechanical loading effects are negligible. Procion red and microperoxidase were utilized as short-term (i.e., low MW, transported on the order of minutes) and long-term (i.e., comparatively high MW, transported on the order of hours) molecular tracers, respectively, to elucidate in vivo the pathways and extent of transport in the metacarpus and tibia of 60-day-old (i.e., skeletally immature) and 180-day-old (i.e., skeletally mature) animals. The tracers were introduced intravenously and the animals were maintained in an anesthetized state for the duration of the experiment to prevent physiological loading. In short-term studies, procion red tracer distribution was highly dependent on bone structure, demarcating spaces apposing the vascular pathways in the trabecular bone of immature animals and vascular and extravascular pathways (i.e., specifically, the lacunocanalicular system) within compact bone of mature animals. In longer term studies using microperoxidase, reaction product was concentrated in soft tissues as well as along a subperiosteal and subendosteal band of bone. In contrast, little peroxidase reaction product was observed in the metacarpal and tibial cortices of either immature or mature animals. Based on the results of these studies, diffusive transport mechanisms may suffice to insure an adequate supply of small molecules, such as amino acids, to osteocytes in the midcortex within minutes. In contrast, diffusion alone may not be efficient for transport of larger molecules. Thus, another mechanism of transport, such as convective transport by means of load-induced fluid flow, may be necessary to provide a sufficient supply of larger molecules, such as proteins to osteocytes for the maintenance of metabolic activity, as well as for activation or suppression of modeling processes.