Does PEEK/HA Enhance Bone Formation Compared With PEEK in a Sheep Cervical Fusion Model?

BACKGROUND: Polyetheretherketone (PEEK) has a wide range of clinical applications but does not directly bond to bone. Bulk incorporation of osteoconductive materials including hydroxyapatite (HA) into the PEEK matrix is a potential solution to address the formation of a fibrous tissue layer between PEEK and bone and has not been tested. QUESTIONS/PURPOSES: Using in vivo ovine animal models, we asked: (1) Does PEEK-HA improve cortical and cancellous bone ongrowth compared with PEEK? (2) Does PEEK-HA improve bone ongrowth and fusion outcome in a more challenging functional ovine cervical fusion model? METHODS: The in vivo responses of PEEK-HA Enhanced and PEEK-OPTIMA® Natural were evaluated for bone ongrowth in the form of dowels implanted in the cancellous and cortical bone of adult sheep and examined at 4 and 12 weeks as well as interbody cervical fusion at 6, 12, and 26 weeks. The bone-implant interface was evaluated with radiographic and histologic endpoints for a qualitative assessment of direct bone contact of an intervening fibrous tissue later. Gamma-irradiated cortical allograft cages were evaluated as well. RESULTS: Incorporating HA into the PEEK matrix resulted in more direct bone apposition as opposed to the fibrous tissue interface with PEEK alone in the bone ongrowth as well as interbody cervical fusions. No adverse reactions were found at the implant-bone interface for either material. Radiography and histology revealed resorption and fracture of the allograft devices in vivo. CONCLUSIONS: Incorporating HA into PEEK provides a more favorable environment than PEEK alone for bone ongrowth. Cervical fusion was improved with PEEK-HA compared with PEEK alone as well as allograft bone interbody devices. CLINICAL RELEVANCE: Improving the bone-implant interface with a PEEK device by incorporating HA may improve interbody fusion results and requires further clinical studies.

Osseointegration of multiphase anodic spark deposition treated porous titanium implants in an ovine model.

Modification of titanium oxide by multiphase anodic spark deposition (ASD) has the potential to increase bioactivity and hasten osseointegration and biological fixation in uncemented arthroplasty. This study assessed the in vivo performance of control (Ti), plasma-sprayed HA-coated (TiHA) and ASD (Biospark) treated (TiAn) porous titanium implants with a solid core using a standard uncemented implant fixation sheep model. Cortical interfacial shear-strength and bone ingrowth in cortical and cancellous sites were quantified following 12 weeks in situ. Ultimate shear-strength for the Ti, TiHA and TiAn coatings was 33±9.5, 35.4±8.4 and 33.8±7.8 MPa, respectively, which was limited by coating delamination. ASD treatment was associated with significantly higher mean bone ingrowth at both sites. These results support the osteoconductive potential of the BioSpark treatment of porous titanium.

Meniscal allograft sterilisation: effect on biomechanical and histological properties.

Sterilisation of allografts are a crucial step in ensuring safety and viability. Current sterilisation standards such as 25 kGy gamma irradiation (γ) can have adverse effects on the ultrastructure and biomechanical properties of allograft tissue. Supercritical CO2 (SCCO2) technology, represents an improved sterilisation process that potentially preserves tissue properties. This study aimed to test the effect of SCCO2 sterilisation on the biomechanical and histological properties of the meniscus and compare this to the current standard of γ. Thirty-two 18-month old ovine menisci were randomly assigned into three groups for sterilisation (SCCO2, γ and control). After treatment, biomechanical indentation testing (stiffness and stress relaxation) or histological analysis [percentage of void, cells and extracellular matrix (ECM) per slide] was undertaken. Both SCCO2 and gamma groups displayed an increase in stiffness and stress relaxation as compared to control, however, this difference was lesser in samples treated with SCCO2. No significant histological quantitative differences were detected between SCCO2 and control specimens. Gamma-treated samples demonstrated a significant increase in void and decrease in ECM. Interestingly, both treatment groups demonstrated a decreasing mean void and increasing ECM percentage when analysed from outer to inner zones. No significant differences were detected in all-endpoints when analysed by section. SCCO2 sterilisation represents a potential feasible alternative to existing sterilization techniques such as γ.

The effects of low-intensity pulsed ultrasound on tendon-bone healing in a transosseous-equivalent sheep rotator cuff model.

PURPOSE: The purpose of this study was to examine the effects Low-intensity Pulsed Ultrasound has on initial tendon-bone healing in a clinically relevant extra-articular transosseous-equivalent ovine rotator cuff model. METHODS: Eight skeletally mature wethers, randomly allocated to either control group (n = 4) or treatment group (n = 4), underwent rotator cuff surgery following injury to the infraspinatus tendon. All animals were killed 28 days post surgery to allow examination of early effects of Low-intensity Pulsed Ultrasound treatment. RESULTS: General improvement in histological appearance of tendon-bone integration was noted in the treatment group. Newly formed woven bone with increased osteoblast activity along the bone surface was evident. A continuum was observed between the tendon and bone in an interdigitated fashion with Sharpey's fibres noted in the treatment group. Low-intensity Pulsed Ultrasound treatment also increased bone mineral density at the tendon-bone interface (p < 0.01), while immunohistochemistry results revealed an increase in the protein expression patterns of VEGF (p = 0.038), RUNX2 (p = 0.02) and Smad4 (p = 0.05). CONCLUSIONS: The results of this study indicate that Low-intensity Pulsed Ultrasound may aid in the initial phase of tendon-bone healing process in patients who have undergone rotator cuff repair. This treatment may also be beneficial following other types of reconstructive surgeries involving the tendon-bone interface.

Relationship between patellar tendon shortening and in vitro kinematics in the ovine stifle joint.

Post-operative patellar tendon shortening induces a distal positioning of the patella in the femoral trochlear groove, which has been associated with pain and impeded mobility. An idealized in vitro model was used to examine the effects of shortening on patellar kinematics. The PT length was progressively reduced by up to 5 mm (1-mm instalments) using a device secured onto the tendon in n = 9 ovine stifles. In vitro 6 degrees-of-freedom motion data for the patellofemoral and tibiofemoral joints under conditions of passively induced flexion-extension was acquired electromagnetically. Patellar motion was analysed as a function of both tibial and patellar flexion angles relative to the femoral co-ordinate frame. Linear regression with contrasts was used to compare kinematic changes for each shortening level, with significance set at P<0.01. A mean maximum percentage length reduction of 8.2% was achieved. Patellar flexion was linearly correlated with tibial flexion angle in the intact joint, and this correlation persisted after tendon shortening (R = 0.977, P < 0.01). Patellar kinematics expressed as a function of tibial flexion angle were significantly altered by a mean length decrease of 8.2%, while flexion and proximo-distal shift patterns were significantly affected at lesser shortening levels of 3.1% and 4.7%, respectively. Patellar kinematics expressed as a function of patellar flexion angle remained unchanged. These results suggest that patellar motion within the trochlear groove in the ovine stifle joint follows a repeatable three-dimensional path and that patellar tendon shortening advances the position of the patella along this path, without significantly altering it.

Novel surface modifications of carbon fiber-reinforced polyetheretherketone hip stem in an ovine model.

A carbon fiber-reinforced polymer (CFRP) is theoretically a suitable material for use in an uncemented hip prosthesis considering it can provide isoelastic environment with the surrounding bone, adequate fatigue strength, and a metal-free radiographic evaluation. To date, the selection of polymer material and optimization of both design and surface finish of the prostheses for osseointegration has not been accomplished. This study examined radiographic and histologic results of an uncemented CFRP stem manufactured from carbon fiber-reinforced polyetheretherketone (CFR/PEEK) with a roughened surface and a bioactive treatment in an adult ovine model following a 12-month implantation period. A unilateral hemiarthroplasty of the hip was performed using the CFRP stem or a titanium stem as a control. Four cases with the CFRP stem and five cases with titanium stem were evaluated. Bone on-growth fixation was achieved in two cases with the CFRP stem and in all the cases with the titanium stem. The CFRP cases showed minimal stress shielding while three of five cases with the titanium stem demonstrated typical osteopenia associated with stiff metal stems. Bone on-growth to the uncemented CFRP stem was achieved by using the CFR/PEEK for the material and modifying the surface design and the bioactive surface finish. Bone resorption and osteopenia observed with the Ti stems was not found with the CFRP design.

Influence of electron beam melting manufactured implants on ingrowth and shear strength in an ovine model.

Arthroplasty has evolved with the application of electron beam melting (EBM) in the manufacture of porous mediums for uncemented fixation. Osseointegration of EBM and plasma-sprayed titanium (Ti PS) implant dowels in adult sheep was assessed in graduated cancellous defects and under line-to-line fit in cortical bone. Shear strength and bony ingrowth (EBM) and ongrowth (Ti PS) were assessed after 4 and 12 weeks. Shear strength of EBM exceeded that for Ti PS at 12 weeks (P = .030). Ongrowth achieved by Ti PS in graduated cancellous defects followed a distinctive pattern that correlated to progressively decreasing radial distances between defect and implant, whereas cancellous ingrowth values at 12 weeks for the EBM were not different. Osteoconductive porous structures manufactured using EBM present a viable alternative to traditional surface treatments.

Biomechanical evaluation of four different transosseous-equivalent/suture bridge rotator cuff repairs.

PURPOSE: Evaluate the biomechanical behavior of four variants of the transosseous-equivalent/suture bridge (TOE/SB) repair. METHODS: Four suture bridge (SB) constructs were created using 24 sheep infraspinatus tendon-humerus constructs (n = 6 per technique). The groups were (1) Knotted Standard Suture Bridge (Standard SB)--suture bridge with two medial mattress stitches, (2) Knotted Double Suture Bridge (Double SB)--four medial mattress stitches, (3) Untied Suture Bridge with Medial FT Anchors (Untied SB with FT)--two medial mattress stitches without knots, and (4) Untied Suture Bridge with PushLocks (Untied SB with Pushlocks)--two medial mattress stitches without knots. The contact area footprint was measured with an electronic pressure film prior to dynamic mechanical testing for gapping and testing to failure. RESULTS: The Double SB produced the greatest contact area footprint compared to the other techniques, which did not differ. The Double SB repair with a mean failure load of 456.9N was significantly stronger than the Untied SB with Pushlocks repair at 300N (P = 0.023), the standard SB repair at 295N (P = 0.019), and lastly the Untied SB with FT repair at 284N (P = 0.011). No differences were detected between the two mattress stitch standard SB repair with knots and the knotless two mattress stitch repairs (Untied SB with FT and Untied SB with Pushlocks). Gaps developed during cyclic loading in all repairs apart from the Double SB repair. CONCLUSIONS: The transosseous-equivalent/suture bridge repair with 4 stitches tied in the medial row and maximal lateral suture strand utilization (Double SB) outperformed all other repairs in terms of failure load, tendon-bone contact, and gapping characteristics. The presence of knots in the medial row did not change tendon fixation with respect to failure load, contact area or gapping characteristics.

Effect of surgical fit on integration of cancellous bone and implant cortical bone shear strength for a porous titanium.

Porous scaffold dowels of Ti(6)Al(4)V were prepared and implanted into cancellous and cortical bone sites in adult sheep. Cancellous implants were examined under gap, line-to-line, and press-fit conditions, whereas line-to-line implantation was used in cortical sites. Cortical shear strength increased significantly with time and reached 26.1 ± 8.6 MPa at 12 weeks, accompanied by a concomitant increase in bone integration and remodeling. In cancellous sites, bone integration was well established at 4 and 12 weeks under conditions of press-fit and line-to-line match between implant and surgical defect. New bone growth was also found in the gap conditions, although to a lesser extent. These findings suggest that the porous Ti(6)Al(4)V could prove an effective scaffold material for uncemented fixation in cortical and cancellous sites.

Insights into the mechanics of solid conical microneedle array insertion into skin using the finite element method.

In order to develop optimum microneedle designs, researchers must first develop robust, repeatable and adaptable test methods which are representative of in vivo conditions. However, there is a lack of experimental tools which can accurately comparatively interrogate functional microneedle penetration of tissue. In this study, we seek to develop a state of the art finite element model of microneedle insertion into and penetration of human skin. The developed model employs a 3D hyperelastic, anisotropic pre-stressed multi-layered material which more accurately reflects in vivo skin conditions, while the microneedle is modeled as an array, which can capture the influence of adjacent microneedles on the overall response. Using the developed finite element model, we highlight the importance of accurate computational modeling which can decipher the mechanics of microneedle insertion, including the influence of its position within an array and how it correlates well with experimental observations. In particular, we have concluded that, for our model microneedle array, increasing skin pretension from 0 to 10% strain reduces the penetration force by 13%, ultimate local deformation about the microneedle by 22% and the ultimate penetration efficiency by 15%. We have also concluded that the presence of a base plate limits the penetration efficiency by up to 24%, while the penetration efficiency across a 5 × 1 microneedle array may vary by 27%. This model elucidates, for the first time, the combined effects of skin tension and needle geometry on accurately predicting microneedle penetration efficiency. STATEMENT OF SIGNIFICANCE: Microneedles arrays (MNAs) are medical devices with microscale protrusions, typically designed to penetrate the outermost layer of the skin, that upon optimisation, could lead to disruptive minimally-invasive disease management. However, the mechanics of MNA insertion are complex, due in part to a 'bed of nails' effect, and difficult to elucidate experimentally. Therefore, comparisons between designs, functional assessment of production batches and ultimately the likelihood of clinical translation are challenging to predict. Here, we have develop the most sophisticated in silico model of MNA insertion into pre-tensioned human skin to predict the extent of MNA penetration and therefore the likelihood of successful therapeutic delivery. Researchers can customise this model to predict the penetration efficiency of any MNA design.

Bone ongrowth and mechanical fixation of implants in cortical and cancellous bone.

BACKGROUND: What is the right surface for an implant to achieve biological fixation? Surface technologies can play important roles in encouraging interactions between the implant surface and the host bone to achieve osseointegration. Preclinical animal models provide important insight into in vivo performance related to bone ongrowth and implant fixation. METHODS: A large animal model was used to compare the in vivo response of HA and plasma-sprayed titanium coatings in a well-reported adult ovine model to evaluate bone ongrowth in terms of mechanical properties in cortical sites, and histology and histomorphometry in cortical and cancellous sites at 4 and 12 weeks. RESULTS: Titanium plasma-sprayed surfaces outperformed the HA-coated samples in push-out testing in cortical sites while both surfaces supported new bone ongrowth and remodeling in cortical and cancellous sites. CONCLUSIONS: While both HA and Ti plasma provided an osteoconductive surface for bone ongrowth, the Ti plasma provided a more robust bone-implant interface that ideally would be required for load transfer and implant stability in the longer term.

Simple and customizable method for fabrication of high-aspect ratio microneedle molds using low-cost 3D printing.

We present a simple and customizable microneedle mold fabrication technique using a low-cost desktop SLA 3D printer. As opposed to conventional microneedle fabrication methods, this technique neither requires complex and expensive manufacturing facilities nor expertise in microfabrication. While most low-cost 3D-printed microneedles to date display low aspect ratios and poor tip sharpness, we show that by introducing a two-step "Print & Fill" mold fabrication method, it is possible to obtain high-aspect ratio sharp needles that are capable of penetrating tissue. Studying first the effect of varying design input parameters and print settings, it is shown that printed needles are always shorter than specified. With decreasing input height, needles also begin displaying an increasingly greater than specified needle base diameter. Both factors contribute to low aspect ratio needles when attempting to print sub-millimeter height needles. By setting input height tall enough, it is possible to print needles with high-aspect ratios and tip radii of 20-40 µm. This tip sharpness is smaller than the specified printer resolution. Consequently, high-aspect ratio sharp needle arrays are printed in basins which are backfilled and cured in a second step, leaving sub-millimeter microneedles exposed resulting microneedle arrays which can be used as male masters. Silicone female master molds are then formed from the fabricated microneedle arrays. Using the molds, both carboxymethyl cellulose loaded with rhodamine B as well as polylactic acid microneedle arrays are produced and their quality examined. A skin insertion study is performed to demonstrate the functional capabilities of arrays made from the fabricated molds. This method can be easily adopted by the microneedle research community for in-house master mold fabrication and parametric optimization of microneedle arrays.

Knee kinematics in anatomic anterior cruciate ligament reconstruction with four- and five-strand hamstring tendon autografts.

An alternative to the gold standard fourstrand hamstring tendon autograft for anterior cruciate ligament (ACL) reconstruction is the five-strand graft. The rationale for its use is to increase graft width to better restore the anatomical footprint and biomechanical properties of the native ACL when unable to create a four-strand graft of 8 mm in diameter. To date, there are no trials assessing the use of this wider graft and its effect on the kinematics of the knee. The aim of this study was to determine whether the use of a wider five-strand hamstring tendon autograft in ACL reconstructive surgery better replicated the kinematics of a normal non-injured knee than the gold standard four-strand graft. Forty-four patients (27 operative and 17 normal control) were recruited for this study over a 12-month period. Twenty patients underwent anterior cruciate ligament reconstruction with the four-strand hamstring tendon autograft construct and seven with the five-strand construct. All patients underwent kinematic testing using the KneeKG System (EMOVI, CA) according to a strict testing protocol. The operative group underwent testing at six (T1) and twelve (T2) weeks postoperatively. Analysis of variance was used to compare six degrees of freedom kinematic data across groups and correlations were made between kinematic data and intraoperatively measured graft width. Postoperative kinematic data revealed no statistically significant differences between graft types. At 12 weeks significant differences were seen between the four-strand and control group in the flexion/extension cycle in the preloading phase and at terminal stance. Significant correlations were seen between graft width and rotational stability at Preloading (Pearson's r=0.415) and Maximum Internal Rotation (Femoral Width Pearson's r=0.456 and Tibial Width Pearson's r=0.476) at 12 weeks regardless of graft type. This study demonstrated that to achieve anatomic knee kinematics in primary ACL reconstruction in the first 12 weeks postoperatively, a technique to optimise autograft width using a five-strand hamstring tendon autograft is useful. A relationship was found between graft width and more stable rotational kinematics of the knee during walking, regardless of graft type.

The contribution of the cortical shell to pedicle screw fixation.

BACKGROUND: A pedicle screw insertion technique known as "hubbing" involves the removal of cortical bone around the screw insertion with the aim of improving fixation and decreasing screw loosening. However, the efficacy of this procedure relative to bone density and early loading have not been fully explored. The purpose of this study is to establish the contribution of the cortical layer (hubbing), cancellous density, early loading (toggling) in an idealised model. This is an in vitro laboratory study. METHODS: Synthetic bone blocks with cancellous bulk and a simulated cortical shell were implanted with 6.5 mm pedicle screws. Three key variables were evaluated in this study; density of the simulated bone (10-20 lb/ft3), toggling (±0.5 mm for 10,000 cycles), and the presence or absence of the surrounding cortex (hubbing). Pullout testing after toggling was performed to determine maximum load, stiffness and energy. Results were analyzed to assess interaction and main effects. RESULTS: Removal of the cortex decreased the pullout loads by approximately 1,100 N after toggling. Toggling in the presence of the cortical shell had no effect. However, once the cortical shell is removed damage to the weaker cancellous bone accumulates and further compromises the fixation. CONCLUSIONS: The addition of a cortical layer in the Sawbone model is significant and provides a more realistic model of load sharing. The cortex plays a considerable role in the protection of underlying cancellous bone as well as contributing to initial pullout strength. The results of this study demonstrate a negative synergistic effect when both toggling and hubbing are applied to the weaker bone.

A Biomechanical Comparison of 4-Strand and 5-Strand Anterior Cruciate Ligament Graft Constructs.

Hamstring tendon autografts are used for reconstruction of the anterior cruciate ligament. This study tested the hypothesis that a 5-strand hamstring autograft construct is superior in strength to a 4-strand construct. Four-strand and 5-strand tendon grafts constructs were prepared from ovine flexor tendons and then tested in a uniaxial electromechanical load system with suspensory fixation. The 4-strand and 5-strand constructs were pre-conditioned, stress-relaxed and loaded to ultimate failure. Stress-relaxation, stiffness and ultimate load were compared using a one-way ANOVA. There were no statistical differences in stress-relaxation, initial stiffness, secondary stiffness or ultimate load between 4-strand and 5-strand split tendon graft constructs. Inconsistent failure patterns for both 4-strand and 5-strand constructs were observed. The additional strand in the 5-strand construct may be shielded from stress with additional weakness secondary to the use of suspensory fixation. The potential biological benefit of religamentization and bony integration, with more autologous tissue in the intra-articular space and bony tunnels remains unknown.

Plasma-sprayed titanium coating to polyetheretherketone improves the bone-implant interface.

BACKGROUND CONTEXT: Rapid and stable fixation at the bone-implant interface would be regarded as one of the primary goals to achieve clinical efficacy, regardless of the surgical site. Although mechanical and physical properties of polyetheretherketone (PEEK) provide advantages for implant devices, the hydrophobic nature and the lack of direct bone contact remains a limitation. PURPOSE: To examine the effects of a plasma-sprayed titanium coated PEEK on the mechanical and histologic properties at the bone-implant interface. STUDY SETTING: A preclinical laboratory study. METHODS: Polyetheretherketone and plasma-sprayed titanium coated PEEK implants (Ti-bond; Spinal Elements, Carlsbad, CA, USA) were placed in a line-to-line manner in cortical bone and in a press-fit manner in cancellous bone of adult sheep using an established ovine model. Shear strength was assessed in the cortical sites at 4 and 12 weeks, whereas histology was performed in cortical and cancellous sites at both time points. RESULTS: The titanium coating dramatically improved the shear strength at the bone-implant interface at 4 weeks and continued to improve with time compared with PEEK. Direct bone ongrowth in cancellous and cortical sites can be achieved using a plasma-sprayed titanium coating on PEEK. CONCLUSIONS: Direct bone to implant bonding can be achieved on PEEK in spite of its hydrophobic nature using a plasma-sprayed titanium coating. The plasma-sprayed titanium coating improved mechanical properties in the cortical sites and the histology in cortical and cancellous sites.

Influence of plate-bone contact on cyclically loaded conically coupled locking plate failure.

INTRODUCTION: The maintenance of friction between locking plates and bone is not essential, so that they can be applied with a gap between the plate and underlying bone. We hypothesised that the presence of a gap under a locking plate with a conical coupling mechanism would reduce fixation stability or allow uncoupling of the locking screws from the plate. MATERIALS AND METHODS: Locking plates with two conically coupled locking screws were applied to 6 pairs of adult canine femora. One of each pair had plate to bone contact and the contralateral construct had a 2 mm plate to bone gap. Constructs were cyclically loaded in cantilever bending with 10 percent incremental increases every 1000 cycles at 2 Hz, starting at 250 N. The constructs were fatigued to failure. To evaluate fatigue life of the conical coupling, testing was repeated with aluminium tubing replacing the bone, to eliminate screw-bone cutout failure. RESULTS: The mean sustained loads and cycles to failure in the contact group (420.80, standard error [SE] 14.97 N; 7612.00, SE 574.70 cycles) were significantly greater than in the gap group (337.50, SE 14.97 N; 4252.00, SE 574.70 cycles), (p<0.001). Failure mode of all bone constructs was via screw cutout from the bone. Aluminium tubing constructs failed via screw or plate fatigue and breaking, with one construct having elevation of the plate over the screw head. DISCUSSION AND CONCLUSIONS: Elevation of locking plates with a conical coupling system by 2 mm from the bone reduced construct fatigue life but did not result in screw head uncoupling from the plate.

Lumbar spinal fusion with ß-TCP granules and variable Escherichia coli-derived rhBMP-2 dose.

BACKGROUND CONTEXT: The ideal tissue-engineered solution for any bone graft substitute is to assist in the rapid formation of bone and facilitate fusion. PURPOSE: The present study aims to evaluate this E-BMP-2 (Escherichia coli-derived human bone morphogenetic protein-2) in ovine posterolateral lumbar fusion (PLF) to examine the influence of dose and overall performance in a model with similar graft size and diffusive challenges to the human. STUDY DESIGN/SETTING: In vivo large animal model study. METHODS: An adult ovine PLF was performed in 30 animals with groups of E-BMP-2 with a beta-tricalcium phosphate (ß-TCP) carrier at three different dosages, ß-TCP alone, and autograft from the iliac crest. The fusions were assessed by radiography (X-ray and microcomputed tomography), mechanical testing, and hard-tissue histology with bone labels at 6, 8, and 10 weeks along with routine paraffin histology at 12 weeks. RESULTS: Results showed increasing new bone and fusion rate with E-BMP-2 dose, whereas ß-TCP alone was largely resorbed and did not achieve fusion in this model at 12 weeks. Autograft showed similar grading for the amount of bone between the transverse processes but a lower fusion rate than ß-TCP/E-BMP-2 groups. Bone labels revealed new bone formation at all time points for the E-BMP2 groups, whereas the autograft group showed active bone formation at 10 weeks. Beta-tricalcium phosphate displayed reliable incorporation into the decorticated host bone, whereas limited new bone was found between the transverse processes. At the center of the fusion mass, increased E-BMP-2 dose led to increased incorporation of ß-TCP by new bone. CONCLUSIONS: These results suggest that E-BMP-2 was capable of producing posterolateral fusion in the ovine model that is equal to or superior to autologous graft in terms of fusion rate and mechanical strength. E-BMP-2 dose had considerable influence on ß-TCP granule resorption.

In vivo implant fixation of carbon fiber-reinforced PEEK hip prostheses in an ovine model.

Carbon fiber-reinforced polyetheretherketone (CFR/PEEK) is theoretically suitable as a material for use in hip prostheses, offering excellent biocompatibility, mechanical properties, and the absence of metal ions. To evaluate in vivo fixation methods of CFR/PEEK hip prostheses in bone, we examined radiographic and histological results for cementless or cemented CFR/PEEK hip prostheses in an ovine model with implantation up to 52 weeks. CFR/PEEK cups and stems with rough-textured surfaces plus hydroxyapatite (HA) coatings for cementless fixation and CFR/PEEK cups and stems without HA coating for cement fixation were manufactured based on ovine computed tomography (CT) data. Unilateral total hip arthroplasty was performed using cementless or cemented CFR/PEEK hip prostheses. Five cementless cups and stems and six cemented cups and stems were evaluated. On the femoral side, all cementless stems demonstrated bony ongrowth fixation and all cemented stems demonstrated stable fixation without any gaps at both the bone-cement and cement-stem interfaces. All cementless cases and four of the six cemented cases showed minimal stress shielding. On the acetabular side, two of the five cementless cups demonstrated bony ongrowth fixation. Our results suggest that both cementless and cemented CFR/PEEK stems work well for fixation. Cup fixation may be difficult for both cementless and cemented types in this ovine model, but bone ongrowth fixation on the cup was first seen in two cementless cases. Cementless fixation can be achieved using HA-coated CFR/PEEK implants, even under load-bearing conditions.

The effect of sterilization on the dynamic mechanical properties of paired rabbit cortical bone.

The optimal sterilization method for load bearing allografts remains a clinical concern. Recently, supercritical carbon dioxide (SCCO2) treatments have been shown to be capable of terminally sterilizing a range of bacteria and viruses, while preserving the static mechanical properties of cortical bone. This study evaluated the effect of SCCO2 treatment compared with two doses of gamma irradiation, on clinically relevant dynamic mechanical properties of cortical bone. Quasi-static testing was also performed to compare the impairment of treatment. Whole paired adult rabbit humeri were dissected and randomly assigned into either SCCO2 Control, SCCO2 Additive or gamma irradiation at 10 or 25kGy treatment groups. The bones were treated and mechanically tested in three-point bending, with the lefts acting as controls for the treated rights. Maximum load, energy to failure and stiffness were evaluated from static tests. The number of cycles to failure was determined for fatigue at 6-60% of the ultimate load. This study found that SCCO2 treatment with or without additive did not alter static or dynamic mechanical properties. Gamma irradiation had a deleterious dose dependent effect, with statistically significant (p<0.05) reductions in all static mechanical parameters at 25kGy. This effect was increased in fatigue with statistically significant decreases in both the 10 and 25kGy dose groups. This study highlights the expediency of SCCO2 treatment for load bearing bone allograft processing as terminal sterilization can be achieved while maintaining both the quasi-static and dynamic mechanical properties of the graft.