Mark R. Pitkin

Skin and bone integrated prosthetic pylon: A pilot animal study

Direct skeletal attachment of limb prostheses is a viable alternative to traditional techniques that are based on a socket-residuum interface. Direct skeletal attachment may be a better or even the only method for patients with a very short residuum and high soft-tissue volume. The problem of integrating the prosthetic pylon with residual skin during direct skeletal attachment of a limb prosthesis has not been solved, and the use of a completely porous prosthetic pylon has not been the subject of focused, systematic research. In this in vivo study, we investigated cell (osteocyte, fibroblast, and keratinocyte) adhesion and penetration into the pores of a titanium pylon implanted in Wistar rats. The porous titanium pylon was implanted in the bone of the thigh residua of four rats. Electronic scanning and morphological analysis demonstrated integration of the pylon with the surrounding skin. These findings support the possibility of developing a natural barrier against the infection associated with direct skeletal attachment of limb prostheses.

Effects of Design Variants in Lower-Limb Prostheses on Gait Synergy.

A lower-limb prosthesis is the mechanical device with which an amputees residual limb interacts with the walking surface. The pressure and shear forces that affect the residuum due to prosthesis use are the sources of pain, residual-limb skin problems and gait deviations. Direct approaches to reducing these problems include improving fit, alignment technique and socket design as well as increasing cushioning with socket liners. A summary of typical malalignments and their consequences is presented. The malalignments are considered sources of excessive moments applied to the residuum, which simplifies the analysis of a patients gait. A better design of prosthetic joints could improve prosthetic gait. This article addresses the key mechanical parameter of prosthetic joints, namely the dependence “moment of resistance/angle of deflection.” A mathematical model has been developed that links stresses on the residuum in transtibial amputees with the moment of resistance in the prosthetic ankle at the critical gait phases. Analysis of the model yields a substantial decrease in stresses on the residuum during the most demanding, load-bearing phase of stance if the moment of resistance in the ankle is similar to that seen in the biological ankle joint. Gait study shows use of the experimental rolling-joint prosthetic foot more closely simulates normal gait synergy than the SACH foot.

Design features of implants for direct skeletal attachment of limb prostheses

In direct skeletal attachment (DSA) of limb prostheses, a construct is implanted into an amputees residuum bone and protrudes out of the residuums skin. This technology represents an alternative to traditional suspension of prostheses via various socket systems, with clear indications when the sockets cannot be properly fitted. Contemporary DSA was invented in the 1990s, and several implant systems have been introduced since then. The current review is intended to compare the design features of implants for DSA whose use in humans or in animal studies has been reported in the literature.

Effects of pore size, implantation time, and nano-surface properties on rat skin ingrowth into percutaneous porous titanium implants

The main problem of percutaneous osseointegrated implants is poor skin-implant integration, which may cause infection. This study investigated the effects of pore size (Small, 40-100 μm and Large, 100-160 μm), nanotubular surface treatment (Nano), and duration of implantation (3 and 6 weeks) on skin ingrowth into porous titanium. Each implant type was percutaneously inserted in the back of 35 rats randomly assigned to seven groups. Implant extrusion rate was measured weekly and skin ingrowth into implants was determined histologically after harvesting implants. It was found that all three types of implants demonstrated skin tissue ingrowth of over 30% (at week 3) and 50% (at weeks 4-6) of total implant porous area under the skin; longer implantation resulted in greater skin ingrowth (p < 0.05). Only one case of infection was observed (infection rate 2.9%). Small and Nano groups showed the same implant extrusion rate which was lower than the Large group rate (0.06 ± 0.01 vs. 0.16 ± 0.02 cm/week; p < 0.05). Ingrowth area was comparable in the Small, Large, and Nano implants. However, qualitatively, the Nano implants showed greatest cellular inhabitation within first 3 weeks. We concluded that percutaneous porous titanium implants allow for skin integration with the potential for a safe seal.

Mechanical Outcomes of a Rolling-Joint Prosthetic Foot and Its Performance in the Dorsiflexion Phase of Transtibial Amputee Gait.

To most closely simulate the performance of a biological human foot, a prosthetic foot should function similarly to the biological foot: The shock absorption, propulsion, balance and dorsiflexion functions of the prosthesis should closely mirror those of the biological foot. Most prosthetic feet currently available have good absorption and propulsion abilities, and some also have good balance functions. However, most prosthetic feet lack proper imitation of the dorsiflexion phase of normal gait. Dorsiflexion is crucial to the gait pattern since most foot flexors are used during this phase. A new rolling-joint prosthetic foot (RJF) has been developed to simulate a more natural moment of resistance in the dorsiflexion phase. The pilot biome-chanical study of one transtibial amputee presented here indicates improved gait performance with use of the RJF.

Mathematical modeling and mechanical and histopathological testing of porous prosthetic pylon for direct skeletal attachment

This article presents recent results in the development of the skin and bone integrated pylon (SBIP) intended for direct skeletal attachment of limb prostheses. In our previous studies of the porous SBIP-1 and SBIP-2 prototypes, the bond site between the porous pylons and residuum bone and skin did not show the inflammation characteristically observed when solid pylons are used. At the same time, porosity diminished the strength of the pylon. To find a reasonable balance between the biological conductivity and the strength of the porous pylon, we developed a mathematical model of the composite permeable structure. A novel manufacturing process was implemented, and the new SBIP-3 prototype was tested mechanically. The minimal strength requirements established earlier for the SBIP were exceeded threefold. The first histopathological analysis of skin, bone, and the implanted SBIP-2 pylons was conducted on two rats and one cat. The histopathological analysis provided new evidence of inflammation-free, deep ingrowth of skin and bone cells throughout the SBIP structure.

Two‐stage implantation of the skin‐ and bone‐integrated pylon seeded with autologous fibroblasts induced into osteoblast differentiation for direct skeletal attachment of limb prostheses

Angio- and osteogenesis following the two-stage (TS) implantation of the skin- and bone-integrated pylon seeded with autologous fibroblasts was evaluated. Two consecutive animal substudies were undertaken: intramedullary subcutaneous implantation (15 rabbits) and a TS transcutaneous implantation (12 rabbits). We observed enhanced osseointegrative properties of the intramedullary porous component seeded with fibroblasts induced into osteoblast differentiation, as compared to the untreated porous titanium pylon. The three-phase scintigraphy and subsequent histological analysis showed that the level of osteogenesis was 1.5-fold higher than in the control group, and significantly so (p < 0.05). The biocompatibility was further proved by the absence of inflammatory response or encapsulation and sequestration on the histology assay. Treatment of the transcutaneous component with autologous fibroblasts was associated with nearly a 2-fold decrease in the period required for the ingrowth of dermal and subdermal soft tissues into the implant surface, as compared to the untreated porous titanium component. Direct dermal attachment to the transcutaneous implant prevented superficial and deep periprosthetic infections in rabbits in vivo.

New method of fixation of in-bone implanted prosthesis

This article presents results on the effectiveness of a new version of the titanium porous composite skin and bone integrated pylon (SBIP). The SBIP is designed for direct skeletal attachment of limb prostheses and was evaluated in a preclinical study with three rabbits. In accordance with the study protocol, a new version of the pylon (SBIP-3) was implanted into the hind leg residuum of three rabbits. The SBIP-3 has side fins that are designed to improve the bond between the bone and pylon. The fins are positioned inside two slots precut in the bone walls; their length can be adjusted to match the thickness of the bone walls. After 13 (animal 1) or 26 (animals 2 and 3) wk, the animals were sacrificed and samples collected for histopathological analysis. The space between the fins and the bone into which they were fit was filled with fibrovascular tissue and woven bone. No substantial inflammation was found. We suggest that if further studies substantiate the present results, the proposed method can become an alternative to the established technique of implanting prostheses into the medullary canal of the hosting bone.

Recording of Electric Signal Passing Through a Pylon in Direct Skeletal Attachment of Leg Prostheses With Neuromuscular Control

Direct recordings were made of electrical signals emanating from the muscles in a rabbits residuum. The signals were transmitted via wires attached on one end to the muscles, and on the other to an external recording system. The cable was held in a titanium tube inside a pylon that had been transcutaneously implanted into the residuums bone. The tube was surrounded by porous titanium cladding to enhance its bond with the bone and with the skin of the residuum. This study was the first known attempt to merge the technology of direct skeletal attachment of limb prostheses with the technology of neuromuscular control of prostheses, providing a safe and reliable passage of the electrical signal from the muscles inside the residuum to the outside recording system.

MECHANICAL PROPERTIES OF TOTALLY PERMEABLE TITANIUM COMPOSITE PYLON FOR DIRECT SKELETAL ATTACHMENT

Composite pylons containing a solid titanium core with drilled holes surrounded by a porous sintered titanium shell have been fabricated and tested in bending along with the raw cores and pylons composed of the porous titanium alone. The new pylons were designed with the concept of enhanced in-growth of bone and skin cells and are intended for direct skeletal attachment of limb prostheses considering requirements for long-lasting anchorage to the residuum bone and a need for a safe skin-implant seal. Load-displacement thresholds were determined after which the integrity of the porous component may be compromised. The composite pylons have a flexural strength and stiffness substantially greater than that of pylons composed of the porous titanium alone. The drilled holes in the solid insert have been shown to have virtually no effect on the flexural strength of the pylon, while meeting a requirement for total permeability of the device for unrestricted cell ingrowth. The predicted strength of the pylons and associated failure modes are in close agreement with those measured.