Histopathological Analysis of PEEK Wear Particle Effects on the Synovial Tissue of Patients.

Introduction. Increasing interest developed in the use of carbon-fiber-reinforced-poly-ether-ether-ketones (CFR-PEEK) as an alternative bearing material in knee arthroplasty. The effects of CFR-PEEK wear in in vitro and animal studies are controversially discussed, as there are no data available concerning human tissue. The aim of this study was to analyze human tissue containing CFR-PEEK as well as UHMWPE wear debris. The authors hypothesized no difference between the used biomaterials. Methods and Materials. In 10 patients during knee revision surgery of a rotating-hinge-knee-implant-design, synovial tissue samples were achieved (tibial inserts: UHMWPE; bushings and flanges: CFR-PEEK). One additional patient received revision surgery without any PEEK components as a control. The tissue was paraffin-embedded, sliced into 2 µm thick sections, and stained with hematoxylin and eosin in a standard process. A modified panoptical staining was also done. Results. A "wear-type" reaction was seen in the testing and the control group. In all samples, the UHMWPE particles were scattered in the tissue or incorporated in giant cells. CFR-PEEK particles were seen as conglomerates and only could be found next to vessels. CFR-PEEK particles showed no giant-cell reactions. In conclusion, the hypothesis has to be rejected. UHMWPE and PEEK showed a different scatter-behavior in human synovial tissue.

Unilateral laminoplasty with lateral mass screw fixation for less invasive decompression of the cervical spine: a biomechanical investigation.

PURPOSE: To compare the stabilization behavior of additional unilateral mass screw fixation with current standard procedures in patients with cervical spondylotic myelopathy (CSM) in a biomechanical study. METHODS: Ten human C2-C7 cervical specimens were tested under various segment conditions: native (NAT), laminoplasty (LP), laminoplasty with unilateral (LPU) or bilateral (LPB) stabilization, laminectomy with bilateral stabilization (LCB), and laminectomy. The instrumented level was from C3 to C6. For each segment condition, in vitro flexibility tests were performed using a spinal simulator and an applied load of ±2.5 Nm. The three-dimensional kinematics of the entire cervical segment in three main loading directions [flexion-extension (FE), lateral bending (LB), and axial rotation (AR)] was measured with an ultrasonic motion analysis system. Analysis of variance followed by a post hoc test was used to determine differences under the specific segment conditions to assess the parameters range of motion (ROM) and neutral zone (NZ). RESULTS: For FE, the total ROM of laminoplasty (-6.3% difference to NAT) and laminectomy (+6.4%) remained at the level of native (p > 0.56), whereas the instrumentations LPU (-37.1%), LPB (-44%), and LCB (-43.2%) lead to significant reductions (p < 0.01) without significant differences in LPU to LPB and LCB (p > 0.38). The same results were found with LB. For AR, the stabilization of all instrumentations was less pronounced, but had the same tendency seen for FE and AR. The results for the NZ showed equivalent values as that for ROM. CONCLUSION: The degree of stabilization was as expected for LC and LCB; namely, no stabilization for LC and maximal stabilization for LCB. LPU exhibited almost the same degree of stabilization as LCB. LPU could be a new treatment option for less invasive decompression for multilevel CSM.

The effect of design parameters of interspinous implants on kinematics and load bearing: an in vitro study.

INTRODUCTION: A number of concepts with controversy approaches are currently discussed for interspinous stabilization (IPS). However, comparative biomechanical studies among the different systems are rare. Nevertheless, it remains unclear which biomechanical characteristics are influenced by different design features of these implants, such as implant stiffness or an additional tension band. Therefore, the aim of the present study was to compare different interspinous implants to investigate the biomechanical impact of IPS implant design on intersegmental kinematics, such as range of motion, neutral zone, center of rotation (COR), as well as load transfer like intradiscal pressure (IDP), to gain additional experience for clinical indications and limitations. MATERIAL AND METHOD: Twelve human lumbar spine specimens were tested in a spine loading apparatus. In vitro flexibility testing was performed by applying pure bending moments of 7.5 Nm without and with additional preload of 400 N in the three principal motion planes. Four interspinous implants, Coflex "COF" (Paradigm Spine, Germany), Wallis "WAL" (Abbott Laboratories, France), DIAM "DIA" (Sofamor Danek, France) and InterActiv (Aesculap AG, Germany) with two treatment options (without dorsal tensioning "IAO" and with dorsal tensioning "IAM") were consecutively tested in comparison to the native situation "NAT" and to a defect situation "DEF" of the functional spinal unit. The tested IPS devices are comprised of a compression stiffness range of 133 to 1,674 N/mm and a tensile stiffness range of 0-39 N/mm. Range of motion, neutral zone, center of rotation and intradiscal pressure were analyzed for all instrumentation steps and load cases. CONCLUSION: For the IPS, we found a correlation between compression stiffness and stabilization in extension. Here, the system with the lowest stiffness, DIA, displayed nearly no stabilization of the treated segment, whereas the system with the highest stiffness, WAL and COF, was most pronounced. This applies also for the correlation between device stiffness and IDP. In flexion only the degree of stabilization is in correlation with the tensile stiffness, whereas the IDP stays constant and is not affected by the different tensile stiffness. IPS is not able to stabilize in the frontal and transversal plane. Furthermore IPS does not substantially alter the location of the COR.

Elevated cytokine expression of different PEEK wear particles compared to UHMWPE in vivo.

Due to their mechanical properties, there has been growing interest in poly-ether-ether-ketone (PEEK) and its composites as bearing material in total and unicompartmental knee arthroplasty. The aim of this study was to analyze the biological activity of wear particles of two different (pitch and PAN) carbon-fiber-reinforced- (CFR-) PEEK varieties in comparison to ultra-high-molecular-weight-polyethylene (UHMWPE) in vivo. The authors hypothesized no difference between the used biomaterials. Wear particle suspensions of the particulate biomaterials were injected into knee joints of Balb/c mice, which were sacrificed after seven days. The cytokine expression (IL-1ß, IL-6, TNF-α) was analyzed immunohistochemically in the synovial layer, the adjacent bone marrow and the articular cartilage. Especially in the bone marrow of the two CFR-PEEK varieties there were increased cytokine expressions compared to the control and UHMWPE group. Furthermore, in the articular cartilage the CFR-PEEK pitch group showed an enhanced cytokine expression, which could be a negative predictor for the use in unicondylar knee systems. As these data suggest an increased proinflammatory potential of CFR-PEEK and its composites in vivo, the initial hypothesis had to be refuted. Summarizing these results, CFR-PEEK seems not to be an attractive alternative to UHMWPE as a bearing material, especially in unicompartmental knee arthroplasty.

The effect of design parameters of dynamic pedicle screw systems on kinematics and load bearing: an in vitro study.

As an alternative treatment for chronic back pain due to disc degeneration motion preserving techniques such as posterior dynamic stabilization (PDS) has been clinically introduced, with the intention to alter the load transfer and the kinematics at the affected level to delay degeneration. However, up to the present, it remains unclear when a PDS is clinically indicated and how the ideal PDS mechanism should be designed to achieve this goal. Therefore, the objective of this study was to compare different PDS devices against rigid fixation to investigate the biomechanical impact of PDS design on stabilization and load transfer in the treated and adjacent cranial segment. Six human lumbar spine specimens (L3-L5) were tested in a spine loading apparatus. In vitro flexibility testing was performed by applying pure bending moments of 7.5 Nm without and with additional preload of 400 N in the three principal motion planes. Four PDS devices, "DYN" (Dynesys(®), Zimmer GmbH, Switzerland), "DSS™" (Paradigm Spine, Wurmlingen, Germany), and two prototypes of dynamic rods, "LSC" with a leaf spring, and "STC" with a spring tube (Aesculap AG, Tuttlingen, Germany), were tested in comparison to a rigid fixation device S(4) (Aesculap AG, Tuttlingen, Germany) "RIG", to the native situation "NAT" and to a defect situation "DEF" of the specimens. The instrumented level was L4-L5. The tested PDS devices comprising a stiffness range for axial stiffness of 10 N/mm to 230 N/mm and for bending stiffness of 3 N/mm to 15 N/mm. Range of motion (ROM), neutral zone (NZ), and intradiscal pressure (IDP) were analyzed for all instrumentation steps and load cases of the instrumented and non-instrumented level. In flexion, extension, and lateral bending, all systems, except STC, showed a significant reduction of ROM and NZ compared to the native situation (p < 0.05). Furthermore, we found no significant difference between DYN and RIG (p > 0.1). In axial rotation, only DSS and STC reduced the ROM significantly (p < 0.005) compared to the native situation, whereas DYN and LSC stayed at the level of the native intersegmental rotation (p > 0.05). A correlation was found between axial stiffness and intersegmental stabilization in the sagittal and frontal plane, but not in the transversal plane where intersegmental stabilization is mainly governed by the systems' ability to withstand shear loads. Furthermore, we observed the systems' capacity to reduce IDP in the treated segment. The adjacent segment does not seem to be affected by the stiffness of the fixation device under the described loading conditions.

Can the method of fixation influence the wear behaviour of ZrN coated unicompartmental mobile knee prostheses?

BACKGROUND: Modern unicompartmental knee prostheses represent a valid alternative to total knee replacement. It is known that variations in clinical alignment lead to altered biomechanics and abnormal wear. The aim of this study was to assess the influence, on wear behaviour, of two different cementing interfaces of the femoral components tested on a knee joint wear simulator. METHODS: The wear tests were run in a knee wear simulator at a frequency of 1.1 Hz for 3 million cycles in accordance with ISO 14243-3. Twelve commercial mobile GUR 1020 UHMWPE meniscus specimens articulated in between 12 cobalt-chromium-molybdenum alloy femoral and tibial components covered by a multi-layer of chromium nitride and a final layer of zirconium nitride ceramic coating to prevent ion release from the substrate. Two wear tests were performed: in the first test, each femoral component was cemented into a custom made metallic-block shaped to perfectly host it. In the second test, synthetic composite femurs received the femoral components on the basis of guidelines used in current surgery. FINDINGS: The two cementing interfaces showed a significantly different wear behaviour, quantified as mean weight loss (P<0.001). Scanning electron microscope examinations of new and tested metallic components showed macro- and micro-pores of few microns on both configurations. INTERPRETATION: The wear pattern observed at 3 million cycles showed differences between the two methods of fixation for the meniscus femoral components.

[In vitro stability study of an improved implant system for minimally invasive transforaminal approach]. / In-vitro-Stabilitätsuntersuchung eines neuartigen Implantatsystems für den minimal-invasiven transforaminalen Zugang.

Calf specimens from the L3-4 and L5-6 levels were used for in vitro stability testing of a new transforaminal lumbar interbody fusion (TLIF) implant. Results were compared with those of the conventional posterior lumbar interbody fusion (PLIF) technique using two cuboid spacers. The specimens were loaded with pure moments of 10 Nm in flexion, extension, lateral bending, and axial rotation without any axial preload. They were allowed to move freely and unconstrained in all directions. In extension the PLIF implants showed slightly higher degrees of stiffness than the TLIF implant. While the conventional PLIF technique results in an increased range of motion by a factor of 2.5 after implant insertion, the TLIF approach prevents segmental destabilization in axial rotation. The facet joint arthrodesis using resorbable pins reveals biomechanically interesting results and will therefore be investigated in further studies.

[Mechanical testing of implant properties of thoracoscopic implantation of ventral spinal stabilizing systems. Comparative study with the ISO/DIS 12189-2 corpectomy model and an improved synthetic model]. / Mechanische Testung der Implantateigenschaften eines thorakoskopisch implantierbaren ventralen Wirbelsäulenstabilisierungssystems. Vergleichende Betrachtung im Korpektomiemodell nach ISO/DIS 12189-2 und in einem neuartigen synthetischen Modell.

A new modular anterior fixation system MACS TL (modular anterior construct system for the thoracic and lumbar spine) has been developed for use in thoracoscopic spondylodesis. This system demonstrates high angular stability and meets the surgical requirements for an endoscopic approach. The objective of the current study was fatigue testing of the MACS TL implant system using a corpectomy model according to ISO/DIS 12189-2 and a synthetic model recently developed by Kotani et al. [6]. The MACS TL system demonstrated good mechanical properties with a high stiffness compared to the published data reviewed. The importance of dynamic testing in a corpectomy model has been demonstrated by comparing the MACS TL plate system with an early prototype, which has not yet been clinically evaluated. The corpectomy model according to Kotani et al. offers an interesting alternative to the ISO/DIS 12189-2 test method for asymmetrically designed and antero-laterally positioned spinal implants due to the unconstrained ball joint.