Load-bearing composite fracture-fixation devices with tailored fibre placement for toy-breed dogs.

Fibre reinforced composites are attractive materials for hard tissue reconstructions, due to the high strength and low flexural modulus. However, lack of contourability in the operation theatre inhibits their clinical applications. The study presents a novel in situ contourable composite implant system for load-bearing conditions. The implant system consists of a thin bioresorbable shell with several cavities, much like bubble-wrap. The central cavity contains a semi-flexible glass fibre preform prepared using Tailored Fibre Placement method. The preform is either pre-impregnated with a light curable resin, or the resin is injected into the cavity during the surgical procedure, followed by light curing. The semi-flexible glass fibre preforms were also examined as separate devices, "miniplates". Two types of miniplates were scrutinized, a simplified pilot design and a spatially refined, "optimized" design. The optimized miniplates were implemented as biostable and bioresorbable versions. The feasibility of the in situ contourable composite implant system was demonstrated. The potential of Tailored Fibre Placement for the semi-flexible glass fibre preforms and miniplates was confirmed in a series of biomechanical tests. However, structural optimization is required. Antebrachial fractures in toy-breeds of dogs are exemplar veterinary applications of the devices; further applications in veterinary and human patients are foreseen.

Quasi-static loading of glass fiber-reinforced composite cervical fusion cage.

OBJECTIVES: Anterior decompression and fusion in cervical spine has become one of the most common procedures in neurosurgery. In the surgery, cervical cage implants made of different biomaterials are used. Our purpose was to create a cervical cage made of glass fiber-reinforced composite (FRC) filled with bioactive glass particles and to characterize its behavior in quasi-static compression/shear stress loading conditions. MATERIALS AND METHODS: FRC cages (n = 6) were manufactured with 2, 4, 6, 8 and 10 layers of glass fiber laminates and thermoset dimethacrylate resin matrix resulting in wall thickness from 0.70 to 2.1 mm. Control cage was a commercial PEEK cage (CeSpaceXP) implant with asymmetrical wall thickness of up 4.0 mm. Interior of the cage was filled with glass particles of the size 500-1250 µm simulating the bioactive glass which are used in FRC cranial implants. The FRC cages were quasi-statically loaded (compressive/shear stress) at a constant speed of 1 mm/min in the air. RESULTS: The average yield strength force (YF) of the control PEEK cage was 3483.6 N (±134.3 N). The average YFs for tested FRC cage with 2, 4, 6, 8 and 10 layers of FRC fabric varied from 1336.5 N (±403.8 N) to 7675.0 N (±670.0 N), respectively. The average ultimate forces (UF) for tested FRC cages varied from 1535.8 N (±406.2 N) to 9975.0 N (±1492.4 N). With six layers of FRC fabric, YF of the FRC cage was comparable to the PEEK implants. CONCLUSIONS: In this study, it was demonstrated that it is possible to manufacture a cervical interbody fusion device made of FRC and filled with bioactive glass with proper load bearing capacities. Because of physical properties of FRC-bioactive glass, the FRC cage might have some advances compared to the state-of-the-art cages, like faster bony union and smaller rate of subsidence, which will be studied in the future.

A Polymer for Application as a Matrix Phase in a Concept of In Situ Curable Bioresorbable Bioactive Load-Bearing Continuous Fiber Reinforced Composite Fracture Fixation Plates.

The use of bioresorbable fracture fixation plates made of aliphatic polyesters have good potential due to good biocompatibility, reduced risk of stress-shielding, and eliminated need for plate removal. However, polyesters are ductile, and their handling properties are limited. We suggested an alternative, PLAMA (PolyLActide functionalized with diMethAcrylate), for the use as the matrix phase for the novel concept of the in situ curable bioresorbable load-bearing composite plate to reduce the limitations of conventional polyesters. The purpose was to obtain a preliminary understanding of the chemical and physical properties and the biological safety of PLAMA from the prospective of the novel concept. Modifications with different molecular masses (PLAMA-500 and PLAMA-1000) were synthesized. The efficiency of curing was assessed by the degree of convergence (DC). The mechanical properties were obtained by tensile test and thermomechanical analysis. The bioresorbability was investigated by immersion in simulated body fluid. The biocompatibility was studied in cell morphology and viability tests. PLAMA-500 showed better DC and mechanical properties, and slower bioresorbability than PLAMA-1000. Both did not prevent proliferation and normal morphological development of cells. We concluded that PLAMA-500 has potential for the use as the matrix material for bioresorbable load-bearing composite fracture fixation plates.

Biological response to an experimental implant for tibial tuberosity advancement in dogs: A pre-clinical study.

In this study, we propose a novel bioresorbable bioactive implant for tibial tuberosity advancement (TTA). The implant consists of a gradually resorbing load-bearing shell which encompasses rapidly resorbing small casings loaded with silica-based bioactive glass (BG) particulates which promote bone formation and reduce the risk of infection. The shell and the casings are manufactured by 3D printing from two medical grade bioresorbable polymers (a polyglycolide/lactide based and a polydioxanone based) that have different degradation rates. The casings are expected to resorb within days after surgery to expose the BG particulates while the shell would retain the load-bearing properties of the implant for the time required by bone healing. Unlike the currently used metallic devices, the novel implant is resorbed and excreted from the body once its purpose is fulfilled. This study presents a logical progression from the in vitro characterisation of the materials and implants to the in vivo investigation of the experimental implants. This included mechanical testing of the materials, finite element analysis of a preliminary design of the novel TTA implant, assessment of the degradation behaviour of the polymers and the ion exchange of BG in simulated body fluid, and investigation of the biological response to the novel implants after implantation in rabbits. The osteointegration of the novel implants was comparable to the osteointegration of Ti6Al4V implants in the control group; the biological efficacy and safety were confirmed. The biological response was in line with the expectations. The proof of concept for the novel TTA implants was demonstrated.

Biostable glass fibre-reinforced dimethacrylate-based composites as potential candidates for fracture fixation plates in toy-breed dogs: Mechanical testing and finite element analysis.

In toy-breed dogs (bodyweight <5 kg), the fractures of the radius and ulna are particularly common and can be caused by minimal trauma. While fracture fixation using metallic plates is a feasible treatment modality, the excessive stiffness of these devices produces the underloading of the bone which may result in the adverse bone remodelling and complications in the healing of the fracture. In this study, we investigated bisphenol A glycidylmethacrylate -based glass fibre reinforced composites as potential alternatives to metals in the devices intended for the fracture fixation of the distal radius in toy-breed dogs. Four composites with different glass fibre reinforcements were prepared as rectangular specimens and as fracture fixation plates. These were mechanically tested in three-point and four-point bending. There were two controls: polyether etherketone reinforced with short carbon fibres (specimens and plates) and commercially available stainless-steel plates. Finite element simulations were used for the assessment of the behaviour of the plates. For the control stainless steel plate, the bending strength was 1.358 N*m, superior to that of any of the composite plates. The composite plate with the matrix reinforced with continuous unidirectional glass fibres had the bending strength of 1.081 N*m, which is sufficient in this clinical context. For the plates made of polyether etherketone reinforced with carbon fibres, the strength was 0.280 N*m. Similar conclusions on the biomechanical behaviour of the plates could be made solely based on the results of the finite element simulations, provided the geometries and the material properties are well defined.

Radiostereometric analysis of the initial stability of internally fixed femoral neck fractures under differential loading.

We examined the feasibility of radiostereometric analysis (RSA) in the assessment of the initial stability of internally fixed femoral neck fractures. The study included 16 patients (mean age 73 years). During surgery, multiple RSA-beads were inserted on both sides of the fracture. Radiographs for RSA were taken in the supine position within the first 3 days and 6, 12, 24, and 52 weeks after surgery. To detect any inducible motion at the fracture-site, radiographs for RSA were taken with the patient resting or applying a load through the fracture. Fracture loading was achieved by the patient pressing the ipsilateral foot as much as tolerated on a force plate while providing a counterforce through both hands. Micromotion exceeding the precision values of RSA (≥0.3 mm for the translation vector and/or ≥1.2 degrees for the rotation vector) was considered significant. Permanent three-dimensional fracture-site displacement was also recorded. Voluntary loading induced fracture-site micromotion, which exhibited a dichotomous distribution. In patients with uncomplicated fracture union, inducible micromotion was detectable only at baseline-if at all. Conversely, fractures that developed a nonunion were characterized by the continuation of inducible micromotion beyond baseline. Permanent fracture-site displacement was, on average, nearly an order of magnitude greater than the inducible micromotion. Fracture unions were characterized by the cessation of permanent fracture-site displacement by 12 weeks. Nonunions presented as outliers in permanent fracture-site displacement. Large-scale studies are warranted to evaluate whether the detection of inducible micromotion beyond baseline could serve as an indicator of insufficient fixation stability. © 2018 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodicals, Inc. on behalf of the Orthopaedic Research Society.

Patient specific glass fiber reinforced composite versus titanium plate: A comparative biomechanical analysis under cyclic dynamic loading.

OBJECTIVES: Free flap fixation with patient specific titanium (TI) plates is commonly performed after oncologic mandible resection, but plate exposure, osseous nonunion and imaging artefacts are associated complications. The aim of this study was to analyze interfragmentary movements and fatigue behaviour of patient specific titanium plates in comparison to a novel glass fiber reinforced composite (GFRC) plate in vitro. METHODS: Two polyurethane fibula segments were fixed to a corresponding mandible (Synbone AG, Malans, CH) with a patient specific 2.0 mm titanium plate (DePuy Synthes, Umkirch, Germany and Materialise, Leuven, Belgium) or one of two patient specific GFRC plates with different glass fiber orientation. Plate fixation to the fibula segments was performed with monocortical non-locking screws in all groups. Plate fixation to the mandible was performed with bicortical locking screws in the titanium group and with bicortical non-locking screws in the GFRC groups. Mastication was simulated via cyclic dynamic loading on the left side at a rate of 1 Hz with increasing peak loading (+0.15 N/cycle, Bionix, MTS, Eden Prairie, USA). A three-dimensional optical measuring system (PONTOS 5 M, GOM, Braunschweig, Germany) was used to determine interfragmentary movements between mandible and fibula segments. RESULTS: Mean plate stiffness of GFRC plates was 431 ±â€¯64 N/mm and 453 ±â€¯70 N/mm versus 560 ±â€¯112 N/mm in the titanium group. No significant differences were found for the number of loading cycles until a vertical displacement of 1.0 mm (p = 0.637) and for vertical displacement over time (p = 0.490). Interosteotomy gap movement differed significantly between titanium and GFRC plates in the right distal (p = 0.001), intermediate (p = 0.006) and left distal gap (p = 0.025). CONCLUSIONS: CAD/CAM titanium plates with locking screws provide increased stiffness and reduced interosteotomy movements in comparison to CAD/CAM glass fiber reinforced composite plates with non-locking titanium screws. Future studies should evaluate the influence of mechanobiologically optimized fixation systems on bone healing in free flap surgery.

Flexural and torsional properties of a glass fiber-reinforced composite diaphyseal bone model with multidirectional fiber orientation.

Although widely used, metallic implants have certain drawbacks in reconstructive bone surgery. Their high stiffness in respect to cortical bone can lead to complications which include periprosthetic fractures and aseptic loosening. In contrast to metallic alloys, fiber-reinforced composites (FRC) composed of a thermoset polymer matrix reinforced with continuous E-glass fibers have elastic properties matching those of bone. We investigated the mechanical properties of straight FRC tubes and FRC bone models representing the diaphysis of rabbit femur prepared from glass fiber/bisphenol A glycidyl methacrylate (BisGMA) - triethylene glycol dimethacrylate (TEGDMA) composite in three-point bending and torsion. Three groups of straight FRC tubes with different fiber orientations were mechanically tested to determine the best design for the FRC bone model. Tube 1 consisted most axially oriented unidirectional fiber roving and fewest bidirectional fiber sleevings. Fiber composition of tube 3 was the opposite. Tube 2 had moderate composition of both fiber types. Tube 2 resisted highest stresses in the mechanical tests and its fiber composition was selected for the FRC bone model. FRC bone model specimens were then prepared and the mechanical properties were compared with those of cadaver rabbit femora. In three-point bending, FRC bone models resisted 39-54% higher maximum load than rabbit femora with similar flexural stiffness. In torsion, FRC bone models resisted 31% higher maximum torque (p < 0.001) and were 38% more rigid (p = 0.001) than rabbit femora. Glass fiber-reinforced composites have good biocompatibility and from a biomechanical perspective, they could be used even in reconstruction of segmental diaphyseal defects. Development of an implant applicable for clinical use requires further studies.

Good stability of a cementless, anatomically designed femoral stem in aging women: a 9-year RSA study of 32 patients.

Background and purpose - We previously reported a transient, bone mineral density (BMD)-dependent early migration of anatomically designed hydroxyapatite-coated femoral stems with ceramic-ceramic bearing surfaces (ABG-II) in aging osteoarthritic women undergoing cementless total hip arthroplasty. To evaluate the clinical significance of the finding, we performed a follow-up study for repeated radiostereometric analysis (RSA) 9 years after surgery. Patients and methods - Of the 53 female patients examined at 2 years post-surgery in the original study, 32 were able to undergo repeated RSA of femoral stem migration at a median of 9 years (7.8-9.3) after surgery. Standard hip radiographs were obtained, and the subjects completed the Harris Hip Score and Western Ontario and McMaster Universities Osteoarthritis Index outcome questionnaires. Results - Paired comparisons revealed no statistically significant migration of the femoral stems between 2 and 9 years post-surgery. 1 patient exhibited minor but progressive RSA stem migration. All radiographs exhibited uniform stem osseointegration. No stem was revised for mechanical loosening. The clinical outcome scores were similar between 2 and 9 years post-surgery. Interpretation - Despite the BMD-related early migration observed during the first 3 postoperative months, the anatomically designed femoral stems in aging women are osseointegrated, as evaluated by RSA and radiographs, and exhibit good clinical function at 9 years.

A long-lasting bisphosphonate partially protects periprosthetic bone, but does not enhance initial stability of uncemented femoral stems: A randomized placebo-controlled trial of women undergoing total hip arthroplasty.

Low bone quality may compromise the success of cementless total hip arthroplasty in high-risk patients such as elderly women. Zoledronic acid is a long-lasting antiresorptive agent, which is known to reduce short-term periprosthetic bone loss. However, its effect on femoral stem stability is not well known. Forty-nine female patients with a mean age of 68 years (range, 51-85 years) scheduled to undergo cementless total hip arthroplasty due to osteoarthritis were randomized in this double-blind, placebo-controlled trial to receive a single postoperative infusion of zoledronic acid or placebo. Patients were evaluated for up to four years postoperatively for femoral stem migration measured by radiostereometric analysis, bone mineral density (BMD) measured by dual X-ray absorptiometry, functional recovery, and patient-reported outcome scores. Implant survival was determined at nine years postoperatively. Zoledronic acid did not reduce the femoral stem migration that occurred predominantly during the settling period of the first 3-6 months. Subsequently, all femoral stems were radiographically osseointegrated. Zoledronic acid maintained periprosthetic BMD, while the expected loss of periprosthetic bone during the first 12 months was found in controls. Thereafter, periprosthetic BMD of Gruen zone 7 decreased even in the zoledronic acid group but remained 14.6% higher than that in the placebo group at four years postoperatively. Functional recovery was comparable across the groups. At nine years postoperatively, no revision arthroplasty had been performed. In conclusion, in women at high-risk for low BMD, zoledronic acid had a long-lasting, partially protective effect on periprosthetic bone loss, but the treatment did not enhance the initial femoral stem stability.

Novel biorenewable composite of wood polysaccharide and polylactic acid for three dimensional printing.

Hemicelluloses, the second most abundant polysaccharide right after cellulose, are in practice still treated as a side-stream in biomass processing industries. In the present study, we report an approach to use a wood-derived and side-stream biopolymer, spruce wood hemicellulose (galactoglucomannan, GGM) to partially replace the synthetic PLA as feedstock material in 3D printing. A solvent blending approach was developed to ensure the even distribution of the formed binary biocomposites. The blends of hemicellulose and PLA with varied ratio up to 25% of hemicellulose were extruded into filaments by hot melt extrusion. 3D scaffold prototypes were successfully printed from the composite filaments by fused deposition modeling 3D printing. Combining with 3D printing technique, the biocompatible and biodegradable feature of spruce wood hemicellulose into the composite scaffolds would potentially boost this new composite material in various biomedical applications such as tissue engineering and drug-eluting scaffolds.

Dicer1 ablation in osterix positive bone forming cells affects cortical bone homeostasis.

The RNAse III enzyme Dicer plays a major role in the processing of microRNAs from large pre-miRNAs. Dicer1 processed microRNAs are known to play a comprehensive role in osteoblast differentiation, bone remodeling and skeletal disorders. Targeted deletion of Dicer1 in osteo-progenitor cells is deleterious to fetal survival whereas targeted deletion in mature osteoblasts leads to an increase in bone mass. To address the role of Dicer1 in post-natal skeletal homeostasis, we generated a pre-osteoblast specific Dicer1 knockout model employing Tamoxifen controllable Cre allele, enabling us, via tamoxifen administration, to time-controllably ablate Dicer1 gene expression in osterix expressing bone forming cells in post-natal mice. Inactivation of Dicer1 in osterix positive bone forming cells led to striking dysregulation of cortical bone formation in pre-pubertal as well as adult mice. Cortical bone thickness was found to be significantly decreased in the Cre+ femora of both young and adult mice. Further, biomechanical testing experiments showed increased ductility, reduced stiffness and altered load at upper yield among the Cre+ tibiae. Our results suggest that Dicer1 processed microRNAs might play an important role in the regulation of post-natal cortical bone formation.

3D printed UV light cured polydimethylsiloxane devices for drug delivery.

The goal of this work was to study the printability of PDMS with a semi-solid extrusion printer in combination with the UV-assisted crosslinking technology using UV-LED light to manufacture drug containing structures. Structures with different pore sizes and different drug loadings were prepared containing prednisolone as a model drug. The work showed that it was possible to print drug-free and drug-loaded drug delivery devices of PDMS with the 3D printing technique used in this study. The required UV-curing time to get sufficient crosslinking yield and mechanical strength was minimum three minutes. The microgram drug release from the printed structures was highest for the most drug loaded structures regardless of the porosity of the devices. By altering the surface area/volume ratio it was possible to print structures with differences in the release rate. This study shows that room-temperature semi-solid extrusion printing 3D printing technique in combination with UV-LED crosslinking is an applicable method in the production of prednisolone containing PDMS devices. Both the extrusion 3D printing and the UV-crosslinking was done at room temperature, which make this manufacturing method an interesting alternative for manufacturing controlled release devices containing temperature susceptible drugs.

Load-bearing capacity and fracture behavior of glass fiber-reinforced composite cranioplasty implants.

BACKGROUND: Glass fiber-reinforced composites (FRCs) have been adapted for routine clinical use in various dental restorations and are presently also used in cranial implants. The aim of this study was to measure the load-bearing capacity and failure type of glass FRC implants during static loading with and without interconnective bars and with different fixation modes. METHODS: Load-bearing capacities of 2 types of FRC implants with 4 different fixation modes were experimentally tested. The sandwich-like FRC implants were made of 2 sheets of woven FRC fabric, which consisted of silanized, woven E-glass fiber fabrics impregnated in BisGMA-TEGDMA monomer resin matrix. The space between the outer and inner surfaces was filled with glass particles. All FRC implants were tested up to a 10-mm deflection with load-bearing capacity determined at 6-mm deflection. The experimental groups were compared using nonparametric Kruskal-Wallis analysis with Steel-Dwass post hoc test. RESULTS: FRC implants underwent elastic and plastic deformation until 6-mm deflection. The loading test did not demonstrate any protrusions of glass fibers or cut fiber even at 10-mm deflection. An elastic and plastic deformation of the implant occurred until the FRC sheets were separated from each other. In the cases of the free-standing setup (no fixation) and the fixation with 6 screws, the FRC implants with 2 interconnective bars showed a significantly higher load-bearing capacity compared with the implant without interconnective bars. CONCLUSIONS: FRC implants used in this study showed a load-bearing capacity which may provide protection for the brain after cranial bone defect reconstruction.

Hydroxyapatite and bioactive glass surfaces for fiber reinforced composite implants via surface ablation by Excimer laser.

In skeletal reconstructions, composites, such as bisphenol-A-glycidyldimethacrylate resin reinforced with glass fibers, are potentially useful alternatives to metallic implants. Recently, we reported a novel method to prepare bioactive surfaces for these composites. Surface etching by Excimer laser was used to expose bioactive glass granules embedded in the resin. The purpose of this study was to analyze two types of bioactive surfaces created by this technique. The surfaces contained bioactive glass and hydroxyapatite granules. The selected processing parameters were adequate for the creation of the surfaces. However, the use of porous hydroxyapatite prevented the complete exposure the granules. In cell culture, for bioactive glass coatings, the pattern of proliferation of MG63 cells was comparable to that in the positive control group (Ti6Al4V) while inferior cell proliferation was observed on the surfaces containing hydroxyapatite granules. Scanning electron microscopy revealed osteointegration of implants with both types of surfaces. The technique is suitable for the exposure of solid bioactive glass granules. However, the long-term performance of the surfaces needs further assessment.

Is Model-based Radiostereometric Analysis Suitable for Clinical Trials of a Cementless Tapered Wedge Femoral Stem?

BACKGROUND: In clinical trials of THA, model-based radiostereometric analysis (RSA) techniques may be less precise than conventional marker-based RSA for measurement of femoral stem rotation. We verified the accuracy and clinical precision of RSA based on computer-aided design models of a cementless tapered wedge femoral stem. QUESTIONS: We asked: (1) Is the accuracy of model-based RSA comparable to that of marker-based RSA? (2) What is the clinical precision of model-based RSA? METHODS: Model-based RSA was performed using combined three-dimensional computer-aided design models of the stem and head provided by the implant manufacturer. The accuracy of model-based RSA was compared with that of marker-based RSA in a phantom model using micromanipulators for controlled translation in three axes (x, y, z) and rotation around the y axis. The clinical precision of model-based RSA was evaluated by double examinations of patients who had arthroplasties (n = 24) in an ongoing trial. The clinical precision was defined as being at an acceptable level if the number of patients needed for a randomized trial would not differ from a trial done with conventional marker-based RSA (15-25 patients per group). RESULTS: The accuracy of model-based RSA was 0.03 mm for subsidence (translation along the y axis) (95% CI for the difference between RSA measurements and actual displacement measured with micrometers, -0.03-0.00) and 0.39° for rotation around the y axis (95% CI, -0.41 to -0.06). The accuracy of marker-based RSA was 0.06 mm for subsidence (95% CI, -0.04-0.01; p = 0.728 compared with model-based RSA) and 0.18° for the y axis rotation (95% CI, -0.23 to -0.07; p = 0.358). The clinical precision of model-based RSA was 0.14 mm for subsidence (95% CI for the difference between double examinations, -0.02-0.04) and 0.79° for the y axis rotation (95% CI, -0.16-0.18). CONCLUSIONS: The accuracy of model-based RSA for measurement of the y axis rotation was not quite as high as that of marker-based RSA, but its clinical precision is at an acceptable level. CLINICAL RELEVANCE: Model-based RSA may be suitable for clinical trials of cementless tapered wedge femoral stem designs.

Bioactive glass surface for fiber reinforced composite implants via surface etching by Excimer laser.

Biostable fiber-reinforced composites (FRC) prepared from bisphenol-A-glycidyldimethacrylate (BisGMA)-based thermosets reinforced with E-glass fibers are promising alternatives to metallic implants due to the excellent fatigue resistance and the mechanical properties matching those of bone. Bioactive glass (BG) granules can be incorporated within the polymer matrix to improve the osteointegration of the FRC implants. However, the creation of a viable surface layer using BG granules is technically challenging. In this study, we investigated the potential of Excimer laser ablation to achieve the selective removal of the matrix to expose the surface of BG granules. A UV-vis spectroscopic study was carried out to investigate the differences in the penetration of light in the thermoset matrix and BG. Thereafter, optimal Excimer laser ablation parameters were established. The formation of a calcium phosphate (CaP) layer on the surface of the laser-ablated specimens was verified in simulated body fluid (SBF). In addition, the proliferation of MG63 cells on the surfaces of the laser-ablated specimens was investigated. For the laser-ablated specimens, the pattern of proliferation of MG63 cells was comparable to that in the positive control group (Ti6Al4V). We concluded that Excimer laser ablation has potential for the creation of a bioactive surface on FRC-implants.

Morphological and mechanical characterization of composite bone cement containing polymethylmethacrylate matrix functionalized with trimethoxysilyl and bioactive glass.

Medical polymers of biostable nature (e.g. polymethylmetacrylate, PMMA) are widely used in various clinical applications. In this study, novel PMMA-based composite bone cement was prepared. Bioactive glass (BAG) particulate filler (30wt%) was added to enhance potentially the integration of bone to the cement. The polymer matrix was functionalized with trimethoxysilyl to achieve an interfacial bond between the matrix and the fillers of BAG. The amount of trimethoxysilyl in the monomer system varied from 0 to 75wt%. The effects of dry and wet (simulated body fluid, SBF at +37°C for 5 weeks) conditions were investigated. In total, 20 groups of specimens were prepared. The specimens were subjected to a destructive mechanical test in compression. Scanning electron microscopy (SEM) and micro-computed tomography (micro-CT) were used to study the surface and the three-dimensional morphology of the specimens. The results of the study indicated that the addition of trimethoxysilyl groups led to the formation of a hybrid polymer matrix which, in lower amounts (<10wt% of total weight), did not significantly affect the compression properties. However, when the specimens stored in dry and wet conditions were compared, the water sorption increased the compression strength (~5-10MPa per test group). At the same time, the water sorption also caused an evident porous structure formation for the specimens containing BAG and siloxane formation in the hybrid polymer matrix.

In vitro osteogenic capacity of bone marrow MSCs from postmenopausal women reflect the osseointegration of their cementless hip stems.

Age-related dysfunction of mesenchymal stromal cells (MSCs) is suggested as a main cause of altered bone repair with aging. We recently showed that in postmenopausal women undergoing cementless total hip arthroplasty (THA) aging, low bone mineral density (BMD) and age-related geometric changes of the proximal femur are risk factors for increased early migration and delayed osseointegration of the femoral stems. Extending these analyses, we have here explored how the in vitro osteogenic capacity of bone marrow MSCs from these patients reflects implant osseointegration, representing the patient's in vivo bone healing capacity. A total of 19 postmenopausal women with primary hip osteoarthritis (mean age 65 years, range 50-78) and well-defined bone quality underwent successful preoperative in vitro analysis of osteogenic capacity of iliac crest bone marrow MSCs as well as two-year radiostereometric (RSA) follow-up of femoral stem migration after cementless THA. In patients with MSCs of low osteogenic capacity, the magnitude of cumulative stem subsidence after the settling period of three months was greater (p = 0.028) and the time point for translational osseointegration was significantly delayed (p = 0.030) compared to patients with MSCs of high osteogenic capacity. This study suggests that patients with MSCs of low in vitro osteogenic capacity may display increased stem subsidence after the settling period of 3 months and thereby delayed osseointegration. Our study presents a novel approach for studying the biological progress of hip implant osseointegration and to verify the impact of decreased MSCs function, especially in patients with age-related dysfunction of MSCs and bone healing capacity.

Increased migration of uncemented acetabular cups in female total hip arthroplasty patients with low systemic bone mineral density. A 2-year RSA and 8-year radiographic follow-up study of 34 patients.

BACKGROUND AND PURPOSE: Low bone mineral density (BMD) may jeopardize the initial component stability and delay osseointegration of uncemented acetabular cups in total hip arthroplasty (THA). We measured the migration of uncemented cups in women with low or normal BMD. PATIENTS AND METHODS: We used radiostereometric analysis (RSA) to measure the migration of hydroxyapatite-coated titanium alloy cups with alumina-on-alumina bearings in THA of 34 female patients with a median age of 64 (41-78) years. 10 patients had normal BMD and 24 patients had low systemic BMD (T-score ≤ -1) based on dual-energy X-ray absorptiometry (DXA). Cup migration was followed with RSA for 2 years. Radiographic follow-up was done at a median of 8 (2-10) years. RESULTS: Patients with normal BMD did not show a statistically significant cup migration after the settling period of 3 months, while patients with low BMD had a continuous proximal migration between 3 and 12 months (p = 0.03). These differences in cup migration persisted at 24 months. Based on the perceived risk of cup revision, 14 of the 24 cases were "at risk" (proximal translation of 0.2 to 1.0 mm) in the low-BMD group and 2 of the 10 cases were "at risk" in the normal-BMD group (odds ratio (OR) = 8.0, 95% CI: 1.3-48). The radiographic follow-up showed no radiolucent lines or osteolysis. 2 cups have been revised for fractures of the ceramic bearings, but none for loosening. INTERPRETATION: Low BMD contributed to cup migration beyond the settling period of 3 months, but the migrating cups appeared to osseointegrate eventually.