Properties of an injectable low modulus PMMA bone cement for osteoporotic bone

The use of polymethylmethacrylate (PMMA) cement to reinforce fragile or broken vertebral bodies (vertebroplasty) leads to extensive bone stiffening. Fractures in the adjacent vertebrae may be the consequence of this procedure. PMMA with a reduced Young's modulus may be more suitable. The goal of this study was to produce and characterize stiffness adapted PMMA bone cements. Porous PMMA bone cements were produced by combining PMMA with various volume fractions of an aqueous sodium hyaluronate solution. Porosity, Young's modulus, yield strength, polymerization temperature, setting time, viscosity, injectability, and monomer release of those porous cements were investigated. Samples presented pores with diameters in the range of 25-260 microm and porosity up to 56%. Young's modulus and yield strength decreased from 930 to 50 MPa and from 39 to 1.3 MPa between 0 and 56% porosity, respectively. The polymerization temperature decreased from 68 degrees C (0%, regular cement) to 41 degrees C for cement having 30% aqueous fraction. Setting time decreased from 1020 s (0%, regular cement) to 720 s for the 30% composition. Viscosity of the 30% composition (145 Pa s) was higher than the ones received from regular cement and the 45% composition (100-125 Pa s). The monomer release was in the range of 4-10 mg/mL for all porosities; showing no higher release for the porous materials. The generation of pores using an aqueous gel seems to be a promising method to make the PMMA cement more compliant and lower its mechanical properties to values close to those of cancellous bone.

Cement distribution, volume, and compliance in vertebroplasty: some answers from an anatomy-based nonlinear finite element study

STUDY DESIGN: The biomechanics of vertebral bodies augmented with real distributions of cement were investigated using nonlinear finite element (FE) analysis. OBJECTIVES: To compare stiffness, strength, and stress transfer of augmented versus nonaugmented osteoporotic vertebral bodies under compressive loading. Specifically, to examine how cement distribution, volume, and compliance affect these biomechanical variables. SUMMARY OF BACKGROUND DATA: Previous FE studies suggested that vertebroplasty might alter vertebral stress transfer, leading to adjacent vertebral failure. However, no FE study so far accounted for real cement distributions and bone damage accumulation. METHODS: Twelve vertebral bodies scanned with high-resolution pQCT and tested in compression were augmented with various volumes of cements and scanned again. Nonaugmented and augmented pQCT datasets were converted to FE models, with bone properties modeled with an elastic, plastic and damage constitutive law that was previously calibrated for the nonaugmented models. The cement-bone composite was modeled with a rule of mixture. The nonaugmented and augmented FE models were subjected to compression and their stiffness, strength, and stress map calculated for different cement compliances. RESULTS: Cement distribution dominated the stiffening and strengthening effects of augmentation. Models with cement connecting either the superior or inferior endplate (S/I fillings) were only up to 2 times stiffer than the nonaugmented models with minimal strengthening, whereas those with cement connecting both endplates (S + I fillings) were 1 to 8 times stiffer and 1 to 12 times stronger. Stress increases above and below the cement, which was higher for the S + I cases and was significantly reduced by increasing cement compliance. CONCLUSION: The developed FE approach, which accounts for real cement distributions and bone damage accumulation, provides a refined insight into the mechanics of augmented vertebral bodies. In particular, augmentation with compliant cement bridging both endplates would reduce stress transfer while providing sufficient strengthening.

Vertebroplasty: experimental characterization of polymethylmethacrylate bone cement spreading as a function of viscosity, bone porosity, and flow rate

STUDY DESIGN: This is an experimental study on an artificial vertebra model and human cadaveric spine. OBJECTIVE: Characterization of polymethylmethacrylate (PMMA) bone cement distribution in the vertebral body as a function of cement viscosity, bone porosity, and injection speed. Identification of relevant parameters for improved cement flow predictability and leak prevention in vertebroplasty. SUMMARY OF BACKGROUND DATA: Vertebroplasty is an efficient procedure to treat vertebral fractures and stabilize osteoporotic bone in the spine. Severe complications result from bone cement leakage into the spinal canal or the vascular system. Cement viscosity has been identified as an important parameter for leak prevention but the influence of bone structure and injection speed remain obscure. METHODS: An artificial vertebra model based on open porous aluminum foam was used to simulate bone of known porosity. Fifty-six vertebroplasties with 4 different starting viscosity levels and 2 different injection speeds were performed on artificial vertebrae of 3 different porosities. A validation on a human cadaveric spine was executed. The experiments were radiographically monitored and the shape of the cement clouds quantitatively described with the 2 indicators circularity and mean cement spreading distance. RESULTS: An increase in circularity and a decrease in mean cement spreading distance was observed with increasing viscosity, with the most striking change occurring between 50 and 100 Pas. Larger pores resulted in significantly reduced circularity and increased mean cement spreading distance whereas the effect of injection speed on the 2 indicators was not significant. CONCLUSION: Viscosity is the key factor for reducing the risk of PMMA cement leakage and it should be adapted to the degree of osteoporosis encountered in each patient. It may be advisable to opt for a higher starting viscosity but to inject the material at a faster rate.

Zementaugmentation bei Wirbelmetastasen (Vertebro- und Kyphoplasie) [Cement injection for spinal metastases (vertebroplasty and kyphoplasty)]

Osteolytic lesions of the spine (metastasis, myeloma) can be treated extremely efficiently by percutaneous cement injection. The treatment should be restricted to osteolytic lesions of the vertebral body, and only if a relevant mechanical deterioration is present. If the pedicles and/or the lamina are involved and if there is compression of the spinal canal, the treatment is no longer appropriate. The surgical technique is similar to the treatment of osteoporotic fractures; however, there is definitely a higher risk for cement leakage and the clinical outcome is not as predictable as in osteoporotic fracture treatment. It is important to realize that cement injection per se has no impact on the tumor itself, but provides stability to the vertebral body. An osteolytic lesion without mechanical compromise does not need a vertebroplasty. Patients with tumorous lesions of the spine should be followed by an interdisciplinary team of spine surgeon, oncologist and radio-oncologist.

The effect of pulsed jet lavage in vertebroplasty on injection forces of PMMA bone cement: an animal study

Percutaneous vertebroplasty, comprising of the injection of polymethylmethacrylate (PMMA) into vertebral bodies, is an efficient procedure to stabilize osteoporotic compression fractures as well as other weakening lesions. Besides fat embolism, cement leakage is considered to be one of the major and most severe complications during percutaneous vertebroplasty. The viscosity of the PMMA during injection plays a key role in this context. It was shown in vitro that the best way to lower the risk of cement leakage is to inject the cement at higher viscosity, which is requires high injection forces. Injection forces can be reduced by applying a newly developed lavage technique as it was shown in vitro using human cadaver vertebrae. The purpose of this study was to prove the in vitro results in an in vivo model. The investigation was incorporated in an animal study that was performed to evaluate the cardiovascular reaction on cement augmentation using the lavage technique. Injection forces were measured with instrumentation for 1 cc syringes, additionally acquiring plunger displacement. Averaged injection forces measured, ranged from 12 to 130 N and from 28 to 140 N for the lavage group and the control group, respectively. Normalized injection forces (by viscosity and injection speed) showed a trend to be lower for the lavage group in comparison to the control group (P = 0.073). In conclusion, the clinical relevance on the investigated lavage technique concerning lowering injection forces was only shown by trend in the performed animal study. However, it might well be that the effect is more pronounced for osteoporotic vertebral bodies.

Clinical investigations of polymethylmethacrylate cement viscosity during vertebroplasty and related in vitro measurements

Percutaneous vertebroplasty, comprising an injection of polymethylmethacrylate (PMMA) into vertebral bodies, is a practical procedure for the stabilization of osteoporotic compression fractures as well as other weakening lesions. Cement leakage is considered to be one of the major and most severe complications during percutaneous vertebroplasty. The viscosity of the material plays a key role in this context. In order to enhance the safety for the patient, a rheometer system was developed to measure the cement viscosity intraoperatively. For this development, it is of great importance to know the proper viscosity to start the procedure determined by experienced surgeons and the relation between the time period when different injection devices are used and the cement viscosity. The purpose of the study was to investigate the viscosity ranges for different injection systems during conventional vertebroplasty. Clinically observed viscosity values and related time periods showed high scattering. In order to get a better understanding of the clinical observations, cement viscosity during hardening at different ambient temperatures and by simulation of the body temperature was investigated in vitro. It could be concluded, that the direct viscosity assessment with a rheometer during vertebroplasty can help clinicians to define a lower threshold viscosity and thereby decrease the risk of leakage and make adjustments to their injection technique in real time. Secondly, the acceleration in hardening of PMMA-based cements at body temperature can be useful in minimizing leakages by addressing them with a short injection break.

Differences in endplate deformation of the adjacent and augmented vertebra following cement augmentation

Vertebral cement augmentation can restore the stiffness and strength of a fractured vertebra and relieve chronic pain. Previous finite element analysis, biomechanical tests and clinical studies have indirectly associated new adjacent vertebral fractures following augmentation to altered loading. The aim of this repeated measures in situ biomechanical study was to determine the changes in the adjacent and augmented endplate deformation following cement augmentation of human cadaveric functional spine units (FSU) using micro-computed tomography (micro-CT). The surrounding soft tissue and posterior elements of 22 cadaveric human FSU were removed. FSU were assigned to two groups, control (n = 8) (loaded on day 1 and day 2) and augmented (n = 14) (loaded on day 1, augmented 20% cement fill, and loaded on day 2). The augmented group was further subdivided into a prophylactic augmentation group (n = 9), and vertebrae which spontaneously fractured during loading on day 1 (n = 5). The FSU were axially loaded (200, 1,000, 1,500-2,000 N) within a custom made radiolucent, saline filled loading device. At each loading step, FSUs were scanned using the micro-CT. Endplate heights were determined using custom software. No significant increase in endplate deformation following cement augmentation was noted for the adjacent endplate (P > 0.05). The deformation of the augmented endplate was significantly reduced following cement augmentation for both the prophylactic and fracture group (P < 0.05, P < 0.01, respectively). Endplate deformation of the controls showed no statistically significant differences between loading on day 1 and day 2. A linear relationship was noted between the applied compressive load and endplate deflection (R (2) = 0.58). Evidence of significant endplate deformation differences between unaugmented and augmented FSU, while evident for the augmented endplate, was not present for the adjacent endplate. This non-invasive micro-CT method may also be useful to investigate endplate failure, and parameters that predict vertebral failure.

Temporary zinc oxide-eugenol cement: eugenol quantity in dentin and bond strength of resin composite

Uptake of eugenol from eugenol-containing temporary materials may reduce the adhesion of subsequent resin-based restorations. This study investigated the effect of duration of exposure to zinc oxide–eugenol (ZOE) cement on the quantity of eugenol retained in dentin and on the microtensile bond strength (μTBS) of the resin composite. The ZOE cement (IRM Caps) was applied onto the dentin of human molars (21 per group) for 1, 7, or 28 d. One half of each molar was used to determine the quantity of eugenol (by spectrofluorimetry) and the other half was used for μTBS testing. The ZOE-exposed dentin was treated with either OptiBond FL using phosphoric acid (H3PO4) or with Gluma Classic using ethylenediaminetetraacetic acid (EDTA) conditioning. One group without conditioning (for eugenol quantity) and two groups not exposed to ZOE (for eugenol quantity and μTBS testing) served as controls. The quantity of eugenol ranged between 0.33 and 2.9 nmol mg−1 of dentin (median values). No effect of the duration of exposure to ZOE was found. Conditioning with H3PO4 or EDTA significantly reduced the quantity of eugenol in dentin. Nevertheless, for OptiBond FL, exposure to ZOE significantly decreased the μTBS, regardless of the duration of exposure. For Gluma Classic, the μTBS decreased after exposure to ZOE for 7 and 28 d. OptiBond FL yielded a significantly higher μTBS than did Gluma Classic. Thus, ZOE should be avoided in cavities later to be restored with resin-based materials.

Percutaneous cement augmentation techniques for osteoporotic spinal fractures

Minimally invasive vertebral augmentation-based techniques have been used for the treatment of spinal fractures (osteoporotic and malignant) for approximately 25 years. In this review, we try to give an overview of the current spectrum of percutaneous augmentation techniques, safety aspects and indications. Crucial factors for success are careful patient selection, proper technique and choice of the ideal cement augmentation option. Most compression fractures present a favourable natural course, with reduction of pain and regainment of mobility after a few days to several weeks, whereas other patients experience a progressive collapse and persisting pain. In this situation, percutaneous cement augmentation is an effective treatment option with regards to pain and disability reduction, improvement of quality of life and ambulatory and pulmonary function.

Cement-augmented anterior screw fixation of Type II odontoid fractures in elderly patients with osteoporosis

BACKGROUND CONTEXT: Closed reduction and internal fixation by an anterior approach is an established option for operative treatment of displaced Type II odontoid fractures. In elderly patients, however, inadequate screw purchase in osteoporotic bone can result in severe procedure-related complications. PURPOSE: To improve the stability of odontoid fracture screw fixation in the elderly using a new technique that includes injection of polymethylmethacrylat (PMMA) cement into the C2 body. STUDY DESIGN: Retrospective review of hospital and outpatient records as well as radiographs of elderly patients treated in a university hospital department of orthopedic surgery. PATIENT SAMPLE: Twenty-four elderly patients (8 males and 16 females; mean age, 81 years; range, 62-98 years) with Type II fractures of the dens. OUTCOME MEASURES: Complications, cement leakage (symptomatic/asymptomatic), operation time, loss of reduction, pseudarthrosis and revision surgery, patient complaints, return to normal activities, and signs of neurologic complications were all documented. METHODS: After closed reduction and anterior approach to the inferior border of C2, a guide wire is advanced to the tip of the odontoid under biplanar fluoroscopic control. Before the insertion of one cannulated, self-drilling, short thread screws, a 12 gauge Yamshidi cannula is inserted from anterior and 1 to 3 mL of high-viscosity PMMA cement is injected into the anteroinferior portion of the C2 body. During polymerization of the cement, the screws are further inserted using a lag-screw compression technique. The cervical spine then is immobilized with a soft collar for 8 weeks postoperatively. RESULTS: Anatomical reduction of the dens was achieved in all 24 patients. Mean operative time was 64 minutes (40-90 minutes). Early loss of reduction occurred in three patients, but revision surgery was indicated in only one patient 2 days after primary surgery. One patient died within the first eight postoperative weeks, one within 3 months after surgery. In five patients, asymptomatic cement leakage was observed (into the C1-C2 joint in three patients, into the fracture in two). Conventional radiologic follow-up at 2 and 6 months confirmed anatomical healing in 16 of the19 patients with complete follow-up. In two patients, the fractures healed in slight dorsal angulation; one patient developed a asymptomatic pseudarthrosis. All patients were able to resume their pretrauma level of activity. CONCLUSIONS: Cement augmentation of the screw in Type II odontoid fractures in elderly patients is technically feasible in a clinical setting with a low complication rate. This technique may improve screw purchase, especially in the osteoporotic C2 body.

Indocyanine Green Loaded Biocompatible Nanoparticles: Stabilisation of Indocyanine Green (ICG) Using Biocompatible Silica-Poly (&epsilon-Caprolactone) Grafted Nanocomposites

Indocyanine green (ICG) is a chemically labile compound which needs to be stabilized in aqueous media to be used in biomedical applications. In the present study, poly(ε-caprolactone) (PCL), a semi-crystalline polyester, was used to encapsulate and stabilize ICG in a hydrophobic environment. A hydrophobic and biocompatible nanocomposite was obtained by the process of encapsulating inorganic silica. ICG was embedded in the hydrophobic polymer coating by starting from a well-defined silica (Si) core of either 80 nm or 120 nm diameter, which served as a template for a ‘grafting from’ approach using ε-caprolactone. The obtained nanocomposite Si grafted PCL/ICG was based on silica nanoparticles grafted with PCL, in which ICG was adsorbed. The nanoparticles were characterized by IR spectroscopy, thermogravimetric analysis (TGA) and scanning electron microscopy (SEM). The change in the surface charge and the colloidal stability of the nanoparticles was followed by zeta potential measurements. This approach of synthesizing nanocomposite-based ICG demonstrates a new route to stabilize ICG. We synthesized biocompatible nanoparticles containing a high ICG concentration and exhibiting excellent stability to aqueous decomposition.

The cement prosthesis-like spacer: an intermediate halt on the road to healing.

BACKGROUND Periprosthetic infections remain a devastating problem in the field of joint arthroplasty. In the following study, the results of a two-stage treatment protocol for chronic periprosthetic infections using an intraoperatively molded cement prosthesis-like spacer (CPLS) are presented. METHODS Seventy-five patients with chronically infected knee prosthesis received a two-stage revision procedure with the newly developed CPLS between June 2006 and June 2011. Based on the microorganism involved, patients were grouped into either easy to treat (ETT) or difficult to treat (DTT) and treated accordingly. Range of motion (ROM) and the knee society score (KSS) were utilized for functional assessment. RESULTS Mean duration of the CPLS implant in the DTT group was 3.6 months (range 3-5 months) and in the ETT group 1.3 months (range 0.7-2.5 months). Reinfection rates of the final prosthesis were 9.6% in the ETT and 8.3% in the DTT group with no significant difference between both groups regarding ROM or KSS (P = 0.87, 0.64, resp.). CONCLUSION The results show that ETT patients do not necessitate the same treatment protocol as DTT patients to achieve the same goal, emphasizing the need to differentiate between therapeutic regimes. We also highlight the feasibility of CLPS in two-stage protocols.