3D-printed titanium cages without bone graft outperform PEEK cages with autograft in an animal model

BACKGROUND CONTEXTModernization of 3D printing has allowed for the production of porous titanium interbody cages (3D-pTi) which purportedly optimize implant characteristics and increase osseointegration; however, this remains largely unstudied in vivo.PURPOSETo compare osseointegration of three-dimensional (3D) titanium cages without bone graft and Polyether-ether-ketone (PEEK) interbody cages with autologous iliac crest bone graft (AICBG).STUDY DESIGNAnimal study utilizing an ovine in vivo model of lumbar fusion.METHODSInterbody cages of PEEK or 3D-pTi supplied by Spineart SA (Geneva, Switzerland) were implanted in seven living sheep at L2-L3 and L4-L5, leaving the intervening disc space untreated. Both implant materials were used in each sheep and randomized to the aforementioned disc spaces. Computed tomography (CT) was obtained at 4 weeks and 8 weeks. MicroCT and histological sections were obtained to evaluate osseointegration.RESULTSMicroCT demonstrated osseous in-growth of native cancellous bone in the trabecular architecture of the 3D-pTi interbody cages and no interaction between the PEEK cages with the surrounding native bone. Qualitative histology revealed robust osseointegration in 3D-pTi implants and negligible osseointegration with localized fibrosis in PEEK implants. Evidence of intramembranous and endochondral ossification was apparent with the 3D-pTi cages. Quantitative histometric bone implant contact demonstrated significantly more contact in the 3D-pTi implants versus PEEK (p<.001); region of interest calculations also demonstrated significantly greater osseous and cartilaginous interdigitation at the implant-native bone interface with the 3D-pTi cages (p=.008 and p=.015, respectively).CONCLUSIONS3D-pTi interbody cages without bone graft outperform PEEK interbody cages with AICBG in terms of osseointegration at 4 and 8 weeks postoperatively in an ovine lumbar fusion model.CLINICAL SIGNIFICANCE3D-pTi interbody cages demonstrated early and robust osseointegration without any bone graft or additive osteoinductive agents. This may yield early stability in anterior lumbar arthrodesis and potentially bolster the rate of successful fusion. This could be of particular advantage in patients with spinal neoplasms needing post-ablative arthrodesis, where local autograft use would be ill advised.     

Early bone ingrowth and segmental stability of a trussed titanium cage versus a polyether ether ketone cage in an ovine lumbar interbody fusion model

BACKGROUND CONTEXTLumbar interbody fusion is an effective treatment for unstable spinal segments. However, the time needed to establish a solid bony interbody fusion between the two vertebrae may be longer than twelve months after surgery. During this time window, the instrumented spinal segment is assumed to be at increased risk for instability related complications such as cage migration or subsidence. It is hypothesized that the design of new interbody cages that enable direct osseointegration of the cage at the vertebral endplates, without requiring full bony fusion between the two vertebral endplates, might shorten the time window that the instrumented spinal segment is susceptible to failure.PURPOSETo quantify the bone ingrowth and resulting segmental stability during consolidation of lumbar interbody fusion using two different cage types.STUDY DESIGNPreclinical ovine model.METHODSSeven skeletally mature sheep underwent bi-segmental lumbar interbody fusion surgery with one conventional polyether ether ketone (PEEK) cage, and one newly developed trussed titanium (TT) cage. After a postoperative time period of 13 weeks, non–destructive range of motion testing, and histologic analysis was performed. Additionally, sample specific finite element (FE) analysis was performed to predict the stability of the interbody fusion region alone.RESULTSPhysiological movement of complete spinal motion segments did not reveal significant differences between the segments operated with PEEK and TT cages. The onset of creeping substitution within the cage seemed to be sooner for PEEK cages, which led to significantly higher bone volume over total volume (BV/TV) compared with the TT cages. TT cages showed significantly more direct bone to implant contact (BIC). Although the mean stability of the interbody fusion region alone was not statistically different between the PEEK and TT cages, the variation within the cage types illustrated an all-or-nothing response for the PEEK cages while a more gradual increase in stability was found for the TT cages.CONCLUSIONSSpinal segments operated with conventional PEEK cages were not different from those operated with newly developed TT cages in terms of segmental stability but did show a different mechanism of bone ingrowth and attachment. Based on the differences in development of bony fusion, we hypothesize that TT cages might facilitate increased early segmental stability by direct osseointegration of the cage at the vertebral endplates without requiring complete bony bridging through the cage.CLINICAL SIGNIFICANCEInterbody cage type affects the consolidation process of spinal interbody fusion. Whether different consolidation processes of spinal interbody fusion result in clinically significant differences requires further investigation.     

Comparison in the same intervertebral space between titanium-coated and uncoated PEEK cages in lumbar interbody fusion surgery

BackgroundsDisadvantages of polyetheretherketone (PEEK) cages are their smooth and hydrophobic surfaces and their lack of osteoconductivity. Titanium (Ti) coated PEEK cage has been innovated to overcome these potential concerns. However, few well-designed studies have investigated the efficacy of Ti-coated PEEK cage on interbody fusion in humans. This study aimed to evaluate the efficacy of Ti coating on bone ongrowth at bone–implant surface by simultaneously comparing Ti-coated and uncoated PEEK cages in the same intervertebral space.MethodsThis study is a prospective comparative study for the two different cages. Twenty-six subjects who underwent one-level instrumented posterior lumbar interbody fusion (PLIF) were included. Two PEEK cages [a plasma-sprayed Ti-coated (PTC-PEEK) and an uncoated PEEK cage] were inserted in the same intervertebral space. Fusion rates, cage subsidence, and vertebral cancellous condensation (VCC) around the cage, which indicates bone growth on the surface of each cage, were assessed by thin-slice computed tomography (CT) immediately (within 1 week) and at 3 months postoperatively. A functional radiograph was obtained at 3 and 12 months postoperatively.ResultsTwenty-three subjects showed solid fusion at 3 months postoperatively (fusion rate, 88%). Cage subsidence was not observed. VCC was often observed around the PTC-PEEK cage as evaluated by completely synchronized CT images between immediately and at 3 months postoperatively. Quantified VCC around the cage was significantly larger in the PTC-PEEK cage than in the uncoated PEEK cage (P = 0.01).ConclusionsThe Ti-coated PEEK cage exhibits radiographic signs, suggesting bone ongrowth, as represented by VCC around the cage compared with that around the uncoated PEEK cage. The Ti-coated PEEK cage has the potential to promote solid fusion and to improve clinical outcomes in lumbar interbody fusion surgery.     

Interfacial shear strength of bioactive‐coated carbon fiber reinforced polyetheretherketone after in vivo implantation

Despite the excellent osseointegration of carbon‐fiber‐reinforced polyetheretherketone (CFR/PEEK) with a surface hydroxyapatite (HA) coating, the bone‐implant interfacial shear strength of HA‐coated CFR/PEEK after osseointegration is unclear. We examined the interfacial shear strength of HA‐coated CFR/PEEK implants after in vivo implantation in a rabbit femur‐implant pull‐out test model. HA coating was performed by a newly developed method. Uncoated CFR/PEEK, HA‐coated blasted titanium alloy, and uncoated blasted titanium alloy were used as control implants. The implants were inserted into drilled femoral cortex, and pull‐out tests were conducted after 6 and 12 weeks of implantation to determine maximum interfacial shear strength. The HA‐coated CFR/PEEK (15.7 ± 4.5 MPa) and HA‐coated titanium alloy (14.1 ± 6.0 MPa) exhibited significantly larger interfacial shear strengths than the uncoated CFR/PEEK (7.7 ± 1.8 MPa) and the uncoated titanium alloy (7.8 ± 2.1 MPa) at 6 weeks. At 12 weeks, only the uncoated CFR/PEEK (8.3 ± 3.0 MPa) exhibited a significantly smaller interfacial shear strength, as compared to the HA‐coated CFR/PEEK (17.4 ± 3.6 MPa), HA‐coated titanium alloy (14.2 ± 4.8 MPa), and uncoated titanium alloy (15.0 ± 2.6 MPa). Surface analysis of the removed implants revealed detachment of the HA layer in both the HA‐coated CFR/PEEK and titanium alloy implants. The proposed novel HA coating method of CFR/PEEK significantly increased interfacial shear strength between bone and CFR/PEEK. The achieved interfacial shear strength of the HA‐coated CFR/PEEK implant is of the same level as that of grit‐blasted titanium alloy with HA. © 2012 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 30:1618–1625, 2012     

Porous Titanium‐6 Aluminum‐4 Vanadium Cage Has Better Osseointegration and Less Micromotion Than a Poly‐Ether‐Ether‐Ketone Cage in Sheep Vertebral Fusion

Interbody fusion cages made of poly‐ether‐ether‐ketone (PEEK) have been widely used in clinics for spinal disorders treatment; however, they do not integrate well with surrounding bone tissue. Ti‐6Al‐4V (Ti) has demonstrated greater osteoconductivity than PEEK, but the traditional Ti cage is generally limited by its much greater elastic modulus (110 GPa) than natural bone (0.05–30 GPa). In this study, we developed a porous Ti cage using electron beam melting (EBM) technique to reduce its elastic modulus and compared its spinal fusion efficacy with a PEEK cage in a preclinical sheep anterior cervical fusion model. A porous Ti cage possesses a fully interconnected porous structure (porosity: 68 ± 5.3%; pore size: 710 ± 42 μm) and a similar Young's modulus as natural bone (2.5 ± 0.2 GPa). When implanted in vivo, the porous Ti cage promoted fast bone ingrowth, achieving similar bone volume fraction at 6 months as the PEEK cage without autograft transplantation. Moreover, it promoted better osteointegration with higher degree (2‐10x) of bone‐material binding, demonstrated by histomorphometrical analysis, and significantly higher mechanical stability (P < 0.01), shown by biomechanical testing. The porous Ti cage fabricated by EBM could achieve fast bone ingrowth. In addition, it had better osseointegration and superior mechanical stability than the conventional PEEK cage, demonstrating great potential for clinical application.     

Evaluation of a polyetheretherketone (PEEK) titanium composite interbody spacer in an ovine lumbar interbody fusion model: biomechanical,microcomputed tomographic,and histologic analyses

Background Context

The most commonly used materials used for interbody cages are titanium metal and polymer polyetheretherketone (PEEK). Both of these materials have demonstrated good biocompatibility. A major disadvantage associated with solid titanium cages is their radiopacity, limiting the postoperative monitoring of spinal fusion via standard imaging modalities. However, PEEK is radiolucent, allowing for a temporal assessment of the fusion mass by clinicians. On the other hand, PEEK is hydrophobic, which can limit bony ingrowth. Although both PEEK and titanium have demonstrated clinical success in obtaining a solid spinal fusion, innovations are being developed to improve fusion rates and to create stronger constructs using hybrid additive manufacturing approaches by incorporating both materials into a single interbody device.

Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic protein production on titanium alloy substrates than on poly-ether-ether-ketone

Background contextMultiple biomaterials are clinically available to spine surgeons for performing interbody fusion. Poly-ether-ether-ketone (PEEK) is used frequently for lumbar spine interbody fusion, but alternative materials are also used, including titanium (Ti) alloys. Previously, we showed that osteoblasts exhibit a more differentiated phenotype when grown on machined or grit-blasted titanium aluminum vanadium (Ti6Al4V) alloys with micron-scale roughened surfaces than when grown on smoother Ti6Al4V surfaces or on tissue culture polystyrene (TCPS). We hypothesized that osteoblasts cultured on rough Ti alloy substrates would present a more mature osteoblast phenotype than cells cultured on PEEK, suggesting that textured Ti6Al4V implants may provide a more osteogenic surface for interbody fusion devices.PurposeThe aim of the present study was to compare osteoblast response to smooth Ti6Al4V (sTiAlV) and roughened Ti6Al4V (rTiAlV) with their response to PEEK with respect to differentiation and production of factors associated with osteogenesis.Study designThis in vitro study compared the phenotype of human MG63 osteoblast-like cells cultured on PEEK, sTiAlV, or rTiAlV surfaces and their production of bone morphogenetic proteins (BMPs).MethodsSurface properties of PEEK, sTiAlV, and rTiAlV discs were determined. Human MG63 cells were grown on TCPS and the discs. Confluent cultures were harvested, and cell number, alkaline phosphatase–specific activity, and osteocalcin were measured as indicators of osteoblast maturation. Expression of messenger RNA (mRNA) for BMP2 and BMP4 was measured by real-time polymerase chain reaction. Levels of BMP2, BMP4, and BMP7 proteins were also measured in the conditioned media of the cell cultures.ResultsAlthough roughness measurements for sTiAlV (S_a=0.09±0.01), PEEK (S_a=0.43±0.07), and rTiAlV (S_a=1.81±0.51) varied, substrates had similar contact angles, indicating comparable wettability. Cell morphology differed depending on the surface. Cells cultured on Ti6Al4V had lower cell number and increased alkaline phosphatase specific activity, osteocalcin, BMP2, BMP4, and BMP7 levels in comparison to PEEK. In particular, roughness significantly increased the mRNA levels of BMP2 and BMP4 and secreted levels of BMP4.ConclusionsThese data demonstrate that rTiAlV substrates increase osteoblast maturation and produce an osteogenic environment that contains BMP2, BMP4, and BMP7. The results show that modifying surface structure is sufficient to create an osteogenic environment without addition of exogenous factors, which may induce better and faster bone during interbody fusion.     

Impaction durability of porous polyether-ether-ketone (PEEK) and titanium-coated PEEK interbody fusion devices

Background Context

Various surface modifications, often incorporating roughened or porous surfaces, have recently been introduced to enhance osseointegration of interbody fusion devices. However, these topographical features can be vulnerable to damage during clinical impaction. Despite the potential negative impact of surface damage on clinical outcomes, current testing standards do not replicate clinically relevant impaction loading conditions.

Comparison of 3D-printed titanium-alloy,standard titanium-alloy,and PEEK interbody spacers in an ovine model

BACKGROUND CONTEXTOsseointegration is a pivotal process in achieving a rigid fusion and ultimately a successful clinical outcome following interbody fusion surgery. Advancements in 3D printing technology permit commonly used titanium interbody spacers to be designed with unique architectures, such as a highly interconnected and specific porous structure that mimics the architecture of trabecular bone. Interbody implants with a microscale surface roughness and biomimetic porosity may improve bony ongrowth and ingrowth compared to traditional materials.PURPOSEThe purpose of this study was to compare the osseointegration of lumbar interbody fusion devices composed of surgical-grade polyetheretherketone (PEEK), titanium-alloy (TAV), and 3D-printed porous, biomimetic TAV (3DP) using an in vivo ovine model.STUDY DESIGNIn Vivo Preclinical Animal StudyMETHODSEighteen sheep underwent two-level lateral lumbar interbody fusion randomized with either 3DP, PEEK, or TAV interbody spacers (n=6 levels for each spacer per time point). Postoperative time points were 6 and 12 weeks. Microcomputed tomography and histomorphometry were used to quantify bone volume (BV) within the spacers (ingrowth) and the surface bone apposition ratio (BAR) (ongrowth), respectively.RESULTSThe 3DP-treatment group demonstrated significantly higher BV than the PEEK and TAV groups at 6 weeks (77.3±44.1 mm³, 116.9±43.0 mm³, and 108.7±15.2 mm³, respectively) (p<.05). At 12 weeks, there were no BV differences between groups (p>.05). BV increased in all groups from the 6- to 12-week time points (p<.05). At both time points, the 3DP-treated group (6w: 23.6±10.9%; 12w: 36.5±10.9%) had significantly greater BAR than the PEEK (6w: 8.6±2.1%; 12w: 14.0±5.0%) and TAV (6w: 6.0±5.7%; 12w: 4.1±3.3%) groups (p<.05).CONCLUSIONS3DP interbody spacers facilitated greater total bony ingrowth at 6 weeks, and greater bony ongrowth postoperatively at both 6 and 12 weeks, in comparison to solid PEEK and TAV implants.CLINICAL SIGNIFICANCEBased on these findings, the 3DP spacers may be a reasonable alternative to traditional PEEK and TAV spacers in various clinical applications of interbody fusion.     

Radiological and clinical outcomes of novel Ti/PEEK combined spinal fusion cages: a systematic review and preclinical evaluation

Purpose

The primary objective of this paper was to provide a systematic review of the available clinical studies of Ti/PEEK combined cages in spinal interbody fusion surgeries, focusing on their radiological and clinical outcomes. A secondary aim was to provide a review and evaluation of the in vitro and preclinical studies reported on Ti/PEEK-coated implants.

Methods

A systematic search of the literature was performed in March 2015 via three databases: Medline, Embase and Cochrane library. The following key search terms were combined with synonyms to identify relevant articles: “spinal fusion,” “PEEK,” “titanium” and “cage.”

Results

The novelty of this intervention translates into a paucity of clinical trials, albeit the results of the seven clinical studies that met the criteria for inclusion are promising. All studies reported rate of fusion as a primary outcome. Two studies reported slightly improved fusion in the experimental Ti/PEEK combination cohort, one study identical fusion (91.7 %) and three studies excellent fusion (96, 100 and 94 %) in the Ti/PEEK cohort, although no differences reached statistical significance.

Conclusions

Clinical studies at this early stage demonstrate that Ti/PEEK implants are safe and efficacious, exhibiting similar fusion rates and clinical outcomes compared to the current standard PEEK. There is clinical evidence substantiating the improved radiographic fusion of Ti/PEEK, albeit the differences were not significant. This field is promising, gaining substantial popularity, and further clinical trials are needed in the future to establish Ti/PEEK cages as a mainstay of clinical practice.

     

Platelet-rich plasma combined with hydroxyapatite for lumbar interbody fusion promoted bone formation and decreased an inflammatory pain neuropeptide in rats

STUDY DESIGN.: A prospective interventional trial, using a rat model of lumbar interbody fusion. OBJECTIVE.: To examine the potential efficacy of platelet-rich plasma (PRP) for lumbar interbody fusion, using hydroxyapatite (HA). SUMMARY OF BACKGROUND DATA.: PRP is an autologous product containing a high concentration of platelets in a small volume of plasma and has osteoinductive effects. HA has osteoconductive ability and has been used in combination with autogenous bone for spine fusion. However, reports using PRP with HA for spine fusion are very few. The purpose of this study was to examine the efficacy of PRP with HA for spinal interbody fusion and at the same time to estimate the change in immunoreactivity of the inflammatory neuropeptide, calcitonin gene-related peptide (CGRP), in dorsal root ganglion (DRG) neurons innervating spinal discs. METHODS.: A total of 35 Sprague-Dawley rats were used in this study. Twenty-one rats were used for conducting interbody fusion experiments, 7 rats were used as immunostaining controls, and 7 other rats were used as blood donors for making PRP. L5-L6 interbody fusion was performed on 21 rats using HA + PRP (n = 7), HA + platelet-poor plasma (n = 7), or HA + saline (n = 7). Simultaneously, Fluoro-Gold neurotracer was applied to the intervertebral space to detect DRG neurons innervating the discs. L5-L6 lumbar radiographs were obtained and lumbar DRGs were immunostained for CGRP. The rate of bone union and the change in CGRP immunoreactive DRG neurons innervating the discs were evaluated and compared among groups. RESULTS.: All L5-L6 lumbar discs were fused in the PRP + HA group (fused 7/total 7), whereas only 1 case was fused in the platelet-poor plasma group (1 of 7) and no cases in the HA-only group (0 of 7), which was a significant difference. Upon immunohistochemical analysis, CGRP-positive neurons innervated L5-L6 intervertebral discs in nonunion cases, and these were significantly increased compared with those in union cases. CONCLUSION.: Our study suggests that using PRP with HA was beneficial for spine fusion. This combination may promote bone union and also decrease inflammatory neuropeptide in sensory neurons innervating the discs.     

A comparative study of three biomaterials in an ovine bone defect model

BACKGROUNDPolyetheretherketone (PEEK), and more recently titanium-coated PEEK, have been given serious consideration as biomaterial design choices for spinal interbody implants. Shortcomings in these materials necessitate further innovation into materials research, for example, on PEKK. Common complications such as surface delamination (as with titanium coating) and lack of bone apposition (as with PEEK) indicate the need for a new material that inherently displays preferable bone growth characteristics without sacrificing structural integrity.PURPOSETo compare three biomaterials with respect to their osseointegrative capacity.STUDY DESIGNEvaluate the in vivo material characteristics of three separate biomaterials in an ovine bone defect model: PEEK, titanium-coated PEEK (Ti-coated PEEK), and 3D-printed PEKK. Biomechanical, histologic, and radiographic testing was the basis for evaluation and material characterization.METHODSEight ovine specimens were implanted with one of each of the three types of biomaterials tested in both left and right epicondyles using a femoral bone defect model, and were sacrificed at 8 and 16 weeks. Implants were then analyzed using a push-out method, histologic staining, and various radiographic tests. Industry funding was provided for the completion of this research study, followed by an independent third party review of all relevant data for publication.RESULTSPEKK implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, significant increase in bony apposition over time, and significantly higher push-out strength compared to standard PEEK. The PEKK implant displayed bone growth characteristics comparable to Ti-coated PEEK with significant improvements in implant integrity and radiographic properties.CONCLUSIONThis study found that PEKK displayed preferable characteristics when compared to PEEK and Ti-coated PEEK, and is therefore a potential alternative to their use.     

Covalently‐linked hyaluronan promotes bone formation around Ti implants in a rabbit model

The goal of this study was the in vivo evaluation of nanoporous titanium (Ti) implants bearing a covalently linked surface hyaluronan (HA) layer. Implant surface topography and surface chemistry were previously evaluated by scanning electron micorscopy and X‐ray photoelectron spectroscopy. Results showed that the surface modification process did not affect surface topography, yielding a homogeneously HA‐coated nanotextured implant surface. In vivo evaluation of implants in both cortical and trabecular bone of rabbit femurs showed a significant improvement of both bone‐to‐implant contact and bone ingrowth at HA‐bearing implant interfaces at 4 weeks. The improvement in osteointegration rate was particularly evident in the marrow‐rich trabecular bone (bone‐to‐implant contact: control 22.5%; HA‐coated 69.0%, p < 0.01). Mechanical testing (push‐out test) and evaluation of interfacial bone microhardness confirmed a faster bone maturation around HA‐coated implants (Bone Maturation Index: control 79.1%; HA‐coated 90.6%, p < 0.05). Suggestions based on the biochemical role of HA are presented to account for the observed behavior. Published by Wiley Periodicals, Inc. J Orthop Res 27: 657–663, 2009     

Rough titanium alloys regulate osteoblast production of angiogenic factors

Background contextPolyether-ether-ketone (PEEK) and titanium-aluminum-vanadium (titanium alloy) are used frequently in lumbar spine interbody fusion. Osteoblasts cultured on microstructured titanium generate an environment characterized by increased angiogenic factors and factors that inhibit osteoclast activity mediated by integrin α2β1 signaling. It is not known if this is also true of osteoblasts on titanium alloy or PEEK.PurposeThe purpose of this study was to determine if osteoblasts generate an environment that supports angiogenesis and reduces osteoclastic activity when grown on smooth titanium alloy, rough titanium alloy, or PEEK.Study designThis in vitro study compared angiogenic factor production and integrin gene expression of human osteoblast-like MG63 cells cultured on PEEK or titanium-aluminum-vanadium (titanium alloy).MethodsMG63 cells were grown on PEEK, smooth titanium alloy, or rough titanium alloy. Osteogenic microenvironment was characterized by secretion of osteoprotegerin and transforming growth factor beta-1 (TGF-β1), which inhibit osteoclast activity and angiogenic factors including vascular endothelial growth factor A (VEGF-A), fibroblast growth factor 2 (FGF-2), and angiopoietin-1 (ANG-1). Expression of integrins, transmembrane extracellular matrix recognition proteins, was measured by real-time polymerase chain reaction.ResultsCulture on titanium alloy stimulated osteoprotegerin, TGF-β1, VEGF-A, FGF-2, and angiopoietin-1 production, and levels were greater on rough titanium alloy than on smooth titanium alloy. All factors measured were significantly lower on PEEK than on smooth or rough titanium alloy. Culture on titanium alloy stimulated expression of messenger RNA for integrins that recognize Type I collagen in comparison with PEEK.ConclusionsRough titanium alloy stimulated cells to create an osteogenic-angiogenic microenvironment. The osteogenic-angiogenic responses to titanium alloy were greater than PEEK and greater on rough titanium alloy than on smooth titanium alloy. Surface features regulated expression of integrins important in collagen recognition. These factors may increase bone formation, enhance integration, and improve implant stability in interbody spinal fusions.     

Posterior lumbar interbody fusion (PLIF) with cages and local bone graft in the treatment of spinal stenosis

Posterior lumbar interbody fusion (PLIF) implants are increasingly being used for 360 degrees fusion after decompression of lumbar spinal stenosis combined with degenerative instability. Both titanium and PEEK (PolyEtherEtherKetone) implants are commonly used. Assessing the clinical and radiological results as well as typical complications, such as migration of the cages, is important. In addition, questions such as which radiological parameters can be used to assess successful fusion, and whether the exclusive use of local bone graft is sufficient, are frequently debated. We prospectively evaluated 30 patients after PLIF instrumentation for degenerative lumbar spinal canal stenosis, over a course of 42 months. In all cases, titanium cages and local bone graft were used for spondylodesis. The follow-up protocol of these 30 cases included standardised clinical and radiological evaluation at 3, 6, 12 and 42 months after surgery. Overall satisfactory results were achieved. With one exception, a stable result was achieved with restoration of the intervertebral space in the anterior column. After 42 months of follow-up in most cases, a radiologically visible loss of disc space height can be demonstrated. Clinically relevant migration of the cage in the dorsal direction was detected in one case. Based on our experience, posterior lumbar interbody fusion (PLIF) can be recommended for the treatment of monosegmental and bisegmental spinal stenosis, with or without segmental instability. Postoperative evaluation is mainly based on clinical parameters since the titanium implant affects the diagnostic value of imaging studies and is responsible for artefacts. The results observed in our group of patients suggest that local autologous bone graft procured from the posterior elements after decompression is an adequate material for bone grafting in this procedure.     

Covalent attachment of P15 peptide to titanium surfaces enhances cell attachment,spreading, and osteogenic gene expression

P15, a synthetic 15 amino acid peptide, mimics the cell‐binding domain within the alpha‐1 chain of human collagen is being tested in clinical trials to determine if it enhances bone formation in spinal fusions. We hypothesize that covalent attachment of P15 to titanium implants may also serve to promote osseointegration. To test this hypothesis, we measured osteoblast and mesenchymal cell adhesion, proliferation, and maturation on P15 tethered to a titanium (Ti‐P15) surface. P15 peptide was covalently bonded to titanium alloy surfaces and incubated with osteoblast like cells. Cell toxicity, adhesion, spreading, and differentiation was then evaluated. Real‐time quantitative PCR, Western blot analysis, and fluorescent immunohistochemistry was performed to measure osteoblast gene expression and differentiation. There was no evidence of toxicity. Significant increases in early cell attachment, spreading, and proliferation were observed on the Ti‐P15 surface. Increased filapodial attachments, α₂ integrin expression, and phosphorylated focal adhesion kinase immunostaining indicated activation of integrin signaling pathways. qRT‐PCR analysis indicated there was significant increase in osteogenic differentiation markers in cells grown on Ti‐P15 compared to control‐Ti. Western blotting confirmed these findings. Surface modification of titanium with P15 significantly increased cell attachment, spreading, osteogenic gene expression, and differentiation. Results of this study suggest that Ti‐P15 has the potential to safely enhance bone formation and promote osseointegration of titanium implants. © 2012 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 30:1626–1633, 2012     

Osseointegration and mechanical stability of pyrocarbon and titanium hand implants in a load-bearing in vivo model for small joint arthroplasty

PURPOSE: To test the mechanical stability and histologic osseointegration under load-bearing conditions of 2 different materials, pyrocarbon (Py) and titanium (Ti), in a rabbit model. METHODS: Proximal interphalangeal implants (9 Ti, 8 Py) were placed into rabbit knees and the animals were killed after 3 months. Subsidence was assessed by monthly x-rays. Mechanical stability was measured with a nondestructive pullout test. Implant osseointegration was evaluated by an analysis of the relative implant-calcified bone contact surface on microradiographs and by a histomorphometric analysis of the percentage of bone and connective tissue contact with the implant surface. Histologic examination included assessment of bone apposition on the basis of fluorochromes. RESULTS: Subsidence was found in all 8 Py implants but in none of the Ti group. All 9 Ti implants were mechanically stable; all 8 Py implants were loose. A significantly higher implant-bone contact was found for the Ti group compared with the Py group. Bone apposition increased with time and was highest for the Ti implants 6 weeks after implantation. CONCLUSIONS: In the rabbit model osseointegration of implants was highly dependent on the material. A reliable osseointegration was found for Ti implants. For Py implants no osseointegration or implant stability was achieved. For use of small joints of the hand we therefore recommend Ti-based implants.     

Posterior lumbar interbody fusion using non resorbable poly-ether-ether-ketone versus resorbable poly-l-lactide-co-d,l-lactide fusion devices. Clinical outcome at a minimum of 2-year follow-up

Previous papers on resorbable poly-l-lactide-co-d,l-lactide (PLDLLA) cages in spinal fusion have failed to report adequately on patient-centred clinical outcome measures. Also comparison of PLDLLA cage with a traditionally applicable counterpart has not been previously reported. This is the first randomized prospective study that assesses clinical outcome of PLDLLA cage compared with a poly-ether-ether-ketone (PEEK) implant. Twenty-six patients were randomly assigned to undergo instrumented posterior lumbar interbody fusion (PLIF) whereby either a PEEK cage or a PLDLLA cage was implanted. Clinical outcome based on visual analogue scale scores for leg pain and back pain, as well as Oswestry Disability Index (ODI) and SF-36 questionnaires were documented and analysed. When compared with preoperative values, all clinical parameters have significantly improved in the PEEK group at 2 years after surgery with the exception of SF-36 general health, SF-36 mental health and SF-36 role emotional scores. No clinical parameter showed significant improvement at 2 years after surgery compared with preoperative values in the PLDLLA patient group. Only six patients (50%) in the PLDLLA group showed improvement in the VAS scores for leg and back pain as well as the ODI, as opposed to 10 patients (71%) in the PEEK group. One-third of the patients in the PLDLLA group actually reported worsening of their pain scores and ODI. Three cases of mild to moderate osteolysis were seen in the PLDLLA group. Following up on our preliminary report, these 2-year results confirm the superiority of the PEEK implant to the resorbable PLDLLA implant in aiding spinal fusion and alleviating symptoms following PLIF in patients with degenerative spondylolisthesis associated with either canal stenosis or foramen stenosis or both and emanating from a single lumbar segment.     

Biomaterials and osseous regeneration

The autologous bone graft is commonly used for the repair of bony defects, but its resorption is unpredictable, and there is an inherent morbidity of the donor site. There is a wide range of biomaterials that could be used as bone substitutes, depending on their bioactivity. Among bioactive materials, bioglasses present a linkage between their reactive surface and the adjacent bone although they cannot be colonized by bony ingrowth, moreover their fragility and resorption as particles limit their use. The osteoconductive biomaterials are either represented by the synthetized ceramics, such as hydroxyapatite (HA) or tricalcium phosphate (TCP), or either natural coral and the derived biomaterials of bony matrix. Coral exoskeleton or TCP are highly resorbable, but pure HA is only slightly. Bony ingrowth in osteoconductive materials is limited to the periphery of the implant which does not make it suitable for the repair of large defects. Research is focused on the adjunction of a biologically active substance to the osteoconductive matrix in order to enhance bony ingrowth. Osteoinductive materials such as bone growth factors in combination with a carrier can promote bone healing, especially when bone morphogenetic protein (BMP) is used. Nevertheless, even if their efficacy is demonstrated, their inocuity has not been totally confirmed. Furthermore, the dose used are far superior than in the physiological pathways. Hybrid biomaterials combine an osteoconductive carrier with bone marrow cells. Bone cell cultures could amplify to almost any extent the number of osteogenic cells for such a biomaterial. Bone substitutes will certainly be used in the future to repair bony defects.     

Biomechanical rigidity of an all-polyetheretherketone anterior thoracolumbar spinal reconstruction construct: an in vitro corpectomy model

Background contextPolyetheretherketone (PEEK) is gaining favor as a spinal implant material for interbody and corpectomy cages as well as stabilizing rods. However, there has been little correlation to a relevant and reproducible clinical model. Biomechanical data on PEEK rod constructs have not been reported.PurposeTo quantify the stabilizing effects of PEEK versus titanium (Ti) instrumentation in a thoracolumbar corpectomy model.Study designCorpectomy and randomized instrumentation with an all-Ti, all-PEEK, and hybrid cage/rod construct were performed on cadaveric spines to assess biomechanical differences.MethodsPure unconstrained bending moments were applied to the intact spine and subsequent test constructs in the three physiologic planes using a load control protocol. Motion tracking and analysis were carried out to quantify and compare the range of motion (ROM) between different test constructs in each plane.ResultsFlexion ROM did not show significant changes compared with intact, whereas the all-Ti and hybrid construct reduced ROM significantly in extension. Lateral bending was significantly reduced in all the treatment groups. Rotational stability of the construct was significantly compromised by an all-PEEK spinal construct.ConclusionThe rigidity of the corpectomy construct increased as the amount of Ti in the construct increased. A hybrid construct incorporating a PEEK corpectomy cage and Ti rods may provide adequate stability for an anterior thoracolumbar reconstruction in the sagittal and coronal planes. An all-PEEK construct may provide adequate stability in the coronal and sagittal planes but may compromise the stability significantly in axial rotation. Consideration should be given for supplemental posterior instrumentation if an all-PEEK construct is used in an anterior thoracolumbar spinal reconstruction procedure.