<i>In vivo</i> biocompatibility testing of peek polymer for a spinal implant system: A study in rabbits

Rivard, Charles‐Hilaire; Rhalmi, Souad; Coillard, Christine

doi:10.1002/jbm.10159

Cited by 166 publications

(104 citation statements)

References 9 publications

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“…Nevertheless, following the surgical procedure and implantation of a previous study on the rabbit model [33], the cytoxicity of the nitinol particle debris in contact with the spinal cord dura mater was evaluated. The quantity of the nitinol particles tested in the lumbar site represented the worst-case scenario in case of implant-failure.…”

Section: Discussionmentioning

confidence: 99%

“…Based on a previous investigation on the dura mater reaction to a polymer material [33], the same animal model and surgical approach were used to investigate the dura mater reaction to the nitinol particles. The purpose of this study was to simulate the unlikely event of debris release from the porous nitinol IFD by means of surgical implantation of nitinol particles in the spinal canal of a rabbit model, and therefore to evaluate the toxicity of the nitinol particles in direct contact with the dura mater and nerve roots.To our knowledge, nitinol or any other metallic material has never been investigated in direct contact with the dura mater.…”

Section: Introductionmentioning

confidence: 99%

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The spinal cord dura mater reaction to nitinol and titanium alloy particles: a 1-year study in rabbits

et al. 2007

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This investigation was undertaken to simulate in an animal model the particles released from a porous nitinol interbody fusion device and to evaluate its consequences on the dura mater, spinal cord and nerve roots, lymph nodes (abdominal para-aortic), and organs (kidneys, spleen, pancreas, liver, and lungs). Our objective was to evaluate the compatibility of the nitinol particles with the dura mater in comparison with titanium alloy. In spite of the great use of metallic devices in spine surgery, the proximity of the spinal cord to the devices raised concerns about the effect of the metal debris that might be released onto the neural tissue. Forty-five New Zealand white female rabbits were divided into three groups: nitinol (treated: N = 4 per implantation period), titanium (treated: N = 4 per implantation period), and sham rabbits (control: N = 1 per observation period). The nitinol and titanium alloy particles were implanted in the spinal canal on the dura mater at the lumbar level L2-L3. The rabbits were sacrificed at 1, 4, 12, 26, and 52 weeks. Histologic sections from the regional lymph nodes, organs, from remote and implantation sites, were analyzed for any abnormalities and inflammation. Regardless of the implantation time, both nitinol and titanium particles remained at the implantation site and clung to the spinal cord lining soft tissue of the dura mater. The inflammation was limited to the epidural space around the particles and then reduced from acute to mild chronic during the follow-up. The dura mater, subdural space, nerve roots, and the spinal cord were free of reaction. No particles or abnormalities were found either in the lymph nodes or in the organs. In contact with the dura, the nitinol elicits an inflammatory response similar to that of titanium. The tolerance of nitinol by a sensitive tissue such as the dura mater during the span of 1 year of implantation demonstrated the safety of nitinol and its potential use as an intervertebral fusion device.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The spinal cord dura mater reaction to nitinol and titanium alloy particles: a 1-year study in rabbits

et al. 2007

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“…It has attractive mechanical properties, heat and chemical resistance, good dimensional stability, good biocompatibility and a low elastic modulus close to that of human bone [2][3][4][5] . Moreover, it is also radiolucent and compatible with imaging techniques, such as computed tomography, magnetic resonance imaging and radiography 6,7) .…”

Section: Introductionmentioning

confidence: 99%

Effect of surface pretreatments on resin composite bonding to PEEK

et al. 2016

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This study evaluated the effect of surface pretreatments on resin composite bonding to polyetheretherketone (PEEK). Four groups of surface pretreatment (no pretreatment, etched with 98% sulfuric acid, etched with piranha solution and sandblasting with 50 µm alumina) were performed on PEEK. Surface roughness, Scanning electron microscopy (SEM) and Fourier transform infrared spectroscopy (FTIR) analysis were examined. Shear bond strength (SBS) and interface characteristics were also evaluated after the specimens were bonded with resin materials. Two-way ANOVA analysis revealed significance on two main effects and interactions. Tukey's multiple comparisons test showed that the SBS of resin composite on PEEK were the highest in the group etched with 98% sulfuric acid and bonded with Heliobond ® (p<0.05). All pretreatments produced similar spectra of FTIR patterns. SEM demonstrated porosities and pitting from chemical etching, which suggested a significant influence on the adhesion between PEEK and resin materials.

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“…7,8 However, PEEK has shown both in vivo and in vitro studies to have low bioactive features due to the relatively bioinert surface. [9][10][11] Therefore, many studies have been conducted to improve the biocompatible state of PEEK by incorporating bioactive substances into the substrate or onto the surface as a coating. [12][13][14] The authors have…”

Section: Introductionmentioning

confidence: 99%

Polyether ether ketone implants achieve increased bone fusion when coated with nano-sized hydroxyapatite: a histomorphometric study in rabbit bone

Johansson¹,

Jimbo²,

Naito³

et al. 2016

IJN

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Polyether ether ketone (PEEK) possesses excellent mechanical properties similar to those of human bone and is considered the best alternative material other than titanium for orthopedic spine and trauma implants. However, the deficient osteogenic properties and the bioinertness of PEEK limit its fields of application. The aim of this study was to limit these drawbacks by coating the surface of PEEK with nano-scaled hydroxyapatite (HA) minerals. In the study, the biological response to PEEK, with and without HA coating, was investigated. Twenty-four screw-like and apically perforated implants in the rabbit femur were histologically evaluated at 3 weeks and 12 weeks after surgery. Twelve of the 24 implants were HA coated (test), and the remaining 12 served as uncoated PEEK controls. At 3 weeks and 12 weeks, the mean bone–implant contact was higher for test compared to control ( P <0.05). The bone area inside the threads was comparable in the two groups, but the perforating hole showed more bone area for the HA-coated implants at both healing points ( P <0.01). With these results, we conclude that nano-sized HA coating on PEEK implants significantly improved the osteogenic properties, and in a clinical situation this material composition may serve as an implant where a rapid bone fusion is essential.

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In vivo biocompatibility testing of peek polymer for a spinal implant system: A study in rabbits

Cited by 166 publications

References 9 publications

The spinal cord dura mater reaction to nitinol and titanium alloy particles: a 1-year study in rabbits

The spinal cord dura mater reaction to nitinol and titanium alloy particles: a 1-year study in rabbits

Effect of surface pretreatments on resin composite bonding to PEEK

Polyether ether ketone implants achieve increased bone fusion when coated with nano-sized hydroxyapatite: a histomorphometric study in rabbit bone

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