Skin and bone integrated prosthetic pylon: A pilot animal study

Pitkin, Mark R.; Raykhtsaum, Grigory; Galibin, Оleg V.; Protasov, Mikhail V.; Chihovskaya, Julie V.; Belyaeva, Irina G.

doi:10.1682/jrrd.2005.05.0160

Cited by 29 publications

(42 citation statements)

References 14 publications

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“…In the tissues surrounding the implants at the skin level and under the skin, no signs of inflammation were seen in the experimental SBIP-1 group, while some abscess indicators were seen in the control group. We concluded that the experimental SBIP-1 provided an inviting environment for the surrounding tissues [15].…”

Section: Introductionmentioning

confidence: 80%

“…Following our preliminary in vitro [21] and in vivo [15] studies, we found that a combined pore size of 50 m and porosity of >35 percent were appropriate for skin and bone ingrowth. However, the initial samples of sintered spherical particles were not sufficiently strong to be considered for further in vivo studies.…”

Section: Manufacturing and Mechanical Testingmentioning

confidence: 88%

“…In our preliminary in vivo studies, rats with a porous skin and bone implanted pylon 1 (SBIP-1) [15] showed (1) no signs of inflammation compared with control rats with a solid pylon and (2) clear integration of the pylon with the surrounding skin. Twenty-eight days after the operation, the implants were removed from the animals and investigated with electronic microscopy.…”

Section: Introductionmentioning

confidence: 98%

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Porous composite prosthetic pylon for integration with skin and bone

Pitkin¹,

Raykhtsaum²,

Pilling³

et al. 2007

JRRD

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Abstract-This article presents results of the further development and testing of the "skin and bone integrated pylon" (SBIP-1) for percutaneous (through skin) connection of the residual bone with an external limb prosthesis. We investigated a composite structure (called the SBIP-2) made of titanium particles and fine wires using mathematical modeling and mechanical testing. Results showed that the strength of the pylon was comparable with that of anatomical bone. In vitro and in vivo animal studies on 30 rats showed that the reinforcement of the composite pylon did not compromise its previously shown capacity for inviting skin and bone cell ingrowth through the device. These findings provide evidence for the safe and reliable long-term percutaneous transfer of vital and therapeutic substances, signals, and necessary forces and moments from a prosthetic device to the body.

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Section: Introductionmentioning

confidence: 80%

Section: Manufacturing and Mechanical Testingmentioning

confidence: 88%

Section: Introductionmentioning

confidence: 98%

See 1 more Smart Citation

Porous composite prosthetic pylon for integration with skin and bone

Pitkin¹,

Raykhtsaum²,

Pilling³

et al. 2007

JRRD

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“…The porous composite skin and bone integrated pylon (SBIP) system was developed by Poly-Orth International (Sharon, Massachusetts) with several modifications [21]. The system was intended for a one-stage DSA procedure [22], similar to the Percutaneous Osseointegrated Prostheses system (POP) (IMDS Co-Innovative; Logan, Utah) [23], Endo-Exo Femoral Prosthesis (EEFP) (Eska Orthodynamics GmbH [formerly ESKA IMPLANTS AG]; Lubeck, Germany) [24], and the Intraosseous Transcutaneous Amputation Prosthesis (ITAP) system (Stanmore Group [University College; London, United Kingdom]) [25].…”

Section: Introductionmentioning

confidence: 99%

New method of fixation of in-bone implanted prosthesis

Pitkin

Cassidy²,

Muppavarapu³

et al. 2013

JRRD

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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 pre-clinical 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 wk (animals 2 and 3), 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 fibro-vascular 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 medullar canal of the hosting bone.

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“…Currently, three systems: OPRA [29], EEEF [30], and ITAP [31], have been used in human patients. The POP [32] and SBIP [20, 24] systems are being used in continuing pre clinical and pilot animal studies, and the AEAHBM [33] and UA [34] systems are being used in pilot animal studies.…”

Section: Methodsmentioning

confidence: 99%

Application of the skin and bone integrated pylon with titanium oxide nanotubes and seeded with dermal fibroblasts

Shevtsov

Yudintceva

Блинова

et al. 2015

Prosthetics &Amp; Orthotics International

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Study Design The feasibility and safety of in bone implantation of the skin and bone integrated pylons (SBIP) with nanotubes was investigated in vitro and in vivo in the animal model. Background Direct Direct skeletal attachment of limb prostheses is associated with high rate of transcutaneous infection and loosening of the fixture in the medullary canal prompting for careful assessment of various means for enhancing the skin-device and bone-device interface. The SBIP system constitutes a technological platform for different modifications being evaluated previously. Objectives The current study assessed the combination of nano treatment SBIP with its pre seeding with dermal fibroblasts. We hypothesized that this combination will enhance cell interaction with SBIP compared to nano treatment and the fibroblast seeding when done separately. Methods TiO2 nanotubes were fabricated on the SBIP, and the fibroblasts taken from rabbit's skin were cultured on the pylons before implantation. Results The in vitro experiments demonstrated higher cellular density in the samples with a nanotubular surface than in the non modified pylons used as control. There were no postoperative complications in any of the animals during the 6 month observation period. Subsequent SEM of the pylon extracted from the rabbit's femur showed the stable contact between the pylon and soft tissues in comparison to control samples where the patchy fibrovascular ingrowth was detected. Conclusions The promising results prompt further investigation of the integrative properties of the nanotextured SBIP system seeded with dermal fibroblasts and its optimization for clinical application.

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Skin and bone integrated prosthetic pylon: A pilot animal study

Cited by 29 publications

References 14 publications

Porous composite prosthetic pylon for integration with skin and bone

Porous composite prosthetic pylon for integration with skin and bone

New method of fixation of in-bone implanted prosthesis

Application of the skin and bone integrated pylon with titanium oxide nanotubes and seeded with dermal fibroblasts

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