Porous titanium-nickel for intervertebral fusion in a sheep model: part 2. Surface analysis and nickel release assessment.
Porous titanium-nickel (PTN) devices represent an alternative to traditional cage implants. PTN materials possess an interconnecting network of pores with capillarity properties that may promote bone ingrowth, long-term fixation, and intervertebral fusion without the need for bone grafting. However, their considerable surface area and nickel content may elicit concerns over sensitization potential. Therefore, PTN surface corrosion and nickel release resistance must be carefully studied. To evaluate this possibility, a PTN interbody fusion device (IFD) was compared to a conventional nonporous cage made of TiAlV, a well-known biocompatible biomaterial, in a sheep model. PTN and TiAlV IFDs were inserted at two non-contiguous lumbar sites for 3, 6, and 12 months postsurgery. Their surface was then evaluated by scanning electron microscopy (SEM) combined with backscattered electron analysis (BSE). No evidence of surface corrosion was observed either pre- or postimplantation, regardless of device type. Dosage of nickel ions was also performed with the use of inductively coupled plasma-mass spectrometry (ICP-MS). Blood nickel levels were observed to be within acceptable levels at all postinstrumentation times. Nickel content in PTN-adjacent tissue, as well as in detoxification and remote organs, was equivalent both in PTN-treated and control sheep. Therefore, porous titanium-nickel demonstrated resistance to both in vivo surface corrosion and nickel ion release and compared very well with a conventional titanium implant in the course of a 12-month sheep study.
Assad
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M
R&D Department, Biorthex Inc., 9001 L'Acadie Blvd., Suite 802, Montreal (QC) H4N 3H5, Canada. massad@biorthex.com
Chernyshov
A V
AV
Jarzem
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P
Leroux
M A
MA
Coillard
C
C
Charette
S
S
Rivard
C H
CH
D000497:Alloys; D000818:Animals; D001672:Biocompatible Materials / Q000032:analysis / Q000493:pharmacokinetics; D003343:Corrosion; D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae / Q000601:surgery; D013058:Mass Spectrometry; D008422:Materials Testing; D008855:Microscopy, Electron, Scanning; D023421:Models, Animal; D009532:Nickel / Q000032:analysis / Q000493:pharmacokinetics; D016348:Osseointegration; D012756:Sheep; D013123:Spinal Fusion / Q000295:instrumentation* / Q000379:methods; D013499:Surface Properties; D014025:Titanium / Q000032:analysis / Q000493:pharmacokinetics
D000497:Alloys; D001672:Biocompatible Materials; C040654:titanium nickelide; C031462:titanium alloy (TiAl6V4); D009532:Nickel; D014025:Titanium