Logistical and Economic Advantages of Sterile-Packed, Single-Use Instruments for Total Knee Arthroplasty.

BACKGROUND: Total knee arthroplasty (TKA) is well established as a clinically successful and cost-effective procedure. The transition of the US healthcare system from a fee-for-service model to a value-based care model requires careful examination of patient care to ensure both quality and efficiency. Sterile-packed, single-use instruments have been introduced as a tool to help streamline the operating room (OR) logistics while reducing sterilization requirements. The aim of this study was to examine the potential logistic and economic benefits of single-use instruments compared to traditional, reusable instruments for TKA. METHODS: Four variables related to TKA costs and logistics were modeled in this study: OR turnover time tray sterilization, tray management time, and 90-day infection rates. Model input data for traditional instruments and single-use instruments were based on peer-reviewed literature. A total of 200 sites and 500 cases per site were simulated using the Monte-Carlo-Technique. RESULTS: The median total cost savings with single-use instruments was $994 per case. The largest driver for cost savings was tray sterilization. Sites with higher staff wages and sterilization costs had a larger probability of realizing greater cost savings with adoption of single-use instruments. In cases using single-use instruments, up to 51% of operating days could have accommodated an additional procedure due to the time savings in OR turnover. CONCLUSION: This cost modeling study observed significant potential for logistical and economic improvements in TKA with single-use vs reusable instruments. Although few studies have been conducted to measure the impact of single-use instruments in practice, the results of these simulations motivate further investigation.

Mechanisms of bone fragility in a mouse model of glucocorticoid-treated rheumatoid arthritis: implications for insufficiency fracture risk.

OBJECTIVE: Glucocorticoid (GC) therapy is associated with increased risk of fracture in patients with rheumatoid arthritis (RA). To elucidate the cause of this increased risk, we examined the effects of chronic erosive inflammatory arthritis and GC treatment on bone quality, structure, and biomechanical properties in a murine model. METHODS: Mice with established arthritis and expressing human tumor necrosis factor α (TNFα) transgene (Tg) and their wild-type (WT) littermates were continually treated with GC (prednisolone 5 mg/kg/day via subcutaneous controlled-release pellet) or placebo for 14, 28, or 42 days. Microstructure, biomechanical properties, chemical composition, and morphology of the tibiae and lumbar vertebral bodies were assessed by micro-computed tomography, biomechanical testing, Raman spectroscopy, and histology, respectively. Serum markers of bone turnover were also determined. RESULTS: TNF-Tg and GC treatment additively decreased mechanical strength and stiffness in both the tibiae and the vertebral bodies. GC treatment in the TNF-Tg mice increased the ductility of tibiae under torsional loading. These changes were associated with significant alterations in the biochemical and structural composition of the mineral and organic components of the bone matrix, a decrease in osteoblast activity and bone formation, and an increase in osteoclast activity. CONCLUSION: Our findings indicate that the concomitant decrease in bone strength and increase in bone ductility associated with chronic inflammation and GC therapy, coupled with the significant changes in the bone quality and structure, may increase the susceptibility of the bone to failure under low-energy loading. This may explain the mechanism of symptomatic insufficiency fractures in patients with RA receiving GC therapy who do not have radiographic manifestations of fracture.

Structural and biomechanical responses of osseous healing: a novel murine nonunion model.

BACKGROUND: Understanding the biological mechanisms of why certain fractures are at risk for delayed healing or nonunion requires translational animal models that take advantage of transgenic and other genetic manipulation technologies. Reliable murine nonunion models can be an important tool to understand the biology of nonunion. In this study, we report the results of a recently established model for creating critical defects that lead to atrophic nonunions based on a unique fracture fixation technique. MATERIALS AND METHODS: Subcritical (0.6 mm long) and critical (1.6 mm long) defects were created in femurs of 10-week-old double transgenic (Col1/Col2) mice and stabilized using a custom-designed plate and four screws. Four groups were used: normal, sham, subcritical, and critical. Histology (n = 3 for each group) was analyzed at 2 and 5 weeks, and micro-computed tomography (µCT) and torsional biomechanics (n = 12 for each group) were analyzed at 5 weeks. RESULTS: Subcritical defects showed healing at 2 weeks and were completely healed by 5 weeks, with biomechanical properties not significantly different from normal controls. However, critical defects showed no healing by histology or µCT. These nonunion fractures also displayed no torsional stiffness or strength in 10 of 12 cases. CONCLUSIONS: Our murine fracture model creates reproducible and reliable nonunions and can serve as an ideal platform for studying molecular pathways to contrast healing versus nonhealing events and for evaluating innovative therapeutic approaches to promote healing of a challenging osseous injury.

Pain Relief and Safety Outcomes with Cervical 10 kHz Spinal Cord Stimulation: Systematic Literature Review and Meta-analysis.

BACKGROUND: Chronic pain in head, neck, shoulders and upper limbs is debilitating, and patients usually rely on pain medications or surgery to manage their symptoms. However, given the current opioid epidemic, non-pharmacological interventions that reduce pain, such as spinal cord stimulation (SCS), are needed. The purpose of this study was to review the evidence on paresthesia-free 10 kHz SCS therapy for neck and upper extremity pain. METHODS: Systematic literature search was performed for studies reporting outcomes for cervical 10 kHz SCS using date limits from May 2008 to November 2020. The study results were analyzed and described qualitatively. Additionally, when feasible, meta-analyses of the outcome data, with 95% confidence intervals (CIs), were conducted using both the fixed-effects (FE) and random-effects (RE) models. RESULTS: A total of 15 studies were eligible for inclusion. The proportion of patients who achieved ≥ 50% pain reduction was 83% (95% CI 77-89%) in both the FE and RE models. The proportion of patients who reduced/eliminated their opioid consumption was 39% (95% CI 31-46%) in the FE model and 39% (95% CI 31-48%) in the RE model. Pain or discomfort with the implant, lead migration, and infections were potential risks following cervical SCS. Explant rate was 0.1 (95% CI 0.0-0.2) events per 100 person-months, and no patients in the included studies experienced a neurological complication or paresthesia. CONCLUSION: Findings suggest 10 kHz SCS is a promising, safe, minimally invasive alternative for managing chronic upper limb and neck pain.

Lumbar Discectomy and Reoperation Among Workers' Compensation Cases in Florida and New York: Are Treatment Trends Similar to Other Payer Types?

OBJECTIVE: The aim of this study was to better understand current treatment trends and revision rates for lumbar disc herniation (LDH) in the workers' compensation (WC) population compared with other payer types. METHODS: This was a retrospective analysis of outpatient claims data from Florida and New York during 2014 to 2016. RESULTS: WC patients were less likely to undergo discectomy in Florida (15% vs 19%; P < 0.001) and New York (10% vs 15%; P < 0.001). The odds of WC patients undergoing revision discectomy were 1.5 times greater than patients covered by private payers or all other non-WC payers (P = 0.002). CONCLUSIONS: WC patients undergo discectomy significantly less often than non-WC counterparts, which may be related to a higher risk of reoperation. New evidence-based treatments, such as annular repair, may be critical to advancing care in this unique population.

Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials.

STUDY DESIGN: Systematic review. OBJECTIVES: Superiority claims for medical devices are commonly derived from noninferiority trials, but interpretation of such claims can be challenging. This study aimed to (a) establish the prevalence of noninferiority and superiority designs among spinal device trials, (b) assess the frequency of post hoc superiority claims from noninferiority studies, and (c) critically evaluate the risk of bias in claims that could translate to misleading conclusions. METHODS: Study bias was assessed using the Cochrane Risk of Bias Tool. The risk of bias for the superiority claim was established based on post hoc hypothesis specification, analysis of the intention-to-treat population, post hoc modification of a priori primary outcomes, and sensitivity analyses. RESULTS: Forty-one studies were identified from 1895 records. Nineteen (46%) were noninferiority trials. Fifteen more (37%) were noninferiority trials with a secondary superiority hypothesis specified a priori. Seven (17%) were superiority trials. Of the 34 noninferiority trials, 14 (41%) made superiority claims. A medium or high risk of bias was related to the superiority claim in 9 of those trials (64%), which was due to the analyzed population, lacking sensitivity analyses, claims not being robust during sensitivity analyses, post hoc hypotheses, or modified endpoints. Only 4 of the 14 (29%) noninferiority studies provided low bias in the superiority claim, compared with 3 of the 5 (60%) superiority trials. CONCLUSIONS: Health care decision makers should carefully evaluate the risk of bias in each superiority claim and weigh their conclusions appropriately.

International Society for the Advancement of Spine Surgery Policy 2019-Surgical Treatment of Lumbar Disc Herniation with Radiculopathy.

Lumbar disc herniation (LDH) is a frequent cause of low back pain and radiculopathy, disability, and diminution in quality of life. While nonsurgical care remains the mainstay of initial treatment, symptoms that persist for prolonged periods of time are well treated with discectomy surgery. A large body of evidence shows that, in patients with unremitting symptoms despite a reasonable period of nonsurgical treatment, discectomy surgery is safe and efficacious. In patients with symptoms lasting greater than 6 weeks, various forms of discectomy (open, microtubular, and endoscopic) are superior to continued nonsurgical treatment. The small but significant proportion of patients with recurrent disc herniation experience less improvement overall than patients who do not experience reherniation after primary discectomy. Lumbar discectomy patients with large annular defects (≥6 mm wide) are at a higher risk for recurrent herniation and revision surgery. Annular closure via a bone-anchored device has been shown to decrease the rate of recurrent disc herniation and associated reoperation in these high-risk patients. After a detailed review of the literature, current clinical evidence supports discectomy (open, microtubular, or endoscopic discectomy) as a medically necessary procedure for the treatment of LDH with radiculopathy in indicated patients. Furthermore, there is new scientific evidence that supports the use of bone-anchored annular closure in patients with large annular defects, who are at greater risk for recurrent disc herniation.

Cement augmentation of calcar screws may provide the greatest reduction in predicted screw cut-out risk for proximal humerus plating based on validated parametric computational modelling: Augmenting proximal humerus fracture plating.

AIMS: Fixation of osteoporotic proximal humerus fractures remains challenging even with state-of-the-art locking plates. Despite the demonstrated biomechanical benefit of screw tip augmentation with bone cement, the clinical findings have remained unclear, potentially as the optimal augmentation combinations are unknown. The aim of this study was to systematically evaluate the biomechanical benefits of the augmentation options in a humeral locking plate using finite element analysis (FEA). METHODS: A total of 64 cement augmentation configurations were analyzed using six screws of a locking plate to virtually fix unstable three-part fractures in 24 low-density proximal humerus models under three physiological loading cases (4,608 simulations). The biomechanical benefit of augmentation was evaluated through an established FEA methodology using the average peri-screw bone strain as a validated predictor of cyclic cut-out failure. RESULTS: The biomechanical benefit was already significant with a single cemented screw and increased with the number of augmented screws, but the configuration was highly influential. The best two-screw (mean 23%, SD 3% reduction) and the worst four-screw (mean 22%, SD 5%) combinations performed similarly. The largest benefits were achieved with augmenting screws purchasing into the calcar and having posteriorly located tips. Local bone mineral density was not directly related to the improvement. CONCLUSION: The number and configuration of cemented screws strongly determined how augmentation can alleviate the predicted risk of cut-out failure. Screws purchasing in the calcar and posterior humeral head regions may be prioritized. Although requiring clinical corroborations, these findings may explain the controversial results of previous clinical studies not controlling the choices of screw augmentation.

Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance.

BACKGROUND: Expandable devices for transforaminal or posterior lumbar interbody fusion (TLIF and PLIF, respectively) may enable greater restoration of disc height, foraminal height, and stability within the interbody space than static spacers. Medial-lateral expansion may also increase stability and resistance to subsidence. This study evaluates the clinical and radiographic outcomes from early experience with a bidirectional expandable device. METHODS: This was a retrospective analysis of a continuous series of patients across 3 sites who had previously undergone TLIF or PLIF surgery with a bidirectional expandable interbody fusion device (FlareHawk, Integrity Implants, Inc) at 1 or 2 contiguous levels between L2 and S1. Outcomes included the Oswestry Disability Index (ODI), a visual analog scale (VAS) for back pain or leg pain, radiographic fusion by 1 year of follow-up, subsidence, device migration, and adverse events (AE). RESULTS: There were 58 eligible patients with radiographs for 1-year fusion assessments and 45 patients with ODI, VAS back pain, or VAS leg pain data at baseline and a mean follow-up of 4.5 months. The ODI, VAS back pain, and VAS leg pain scores improved significantly from baseline to final follow-up, with mean improvements of 14.6 ± 19.1, 3.4 ± 2.6, and 3.9 ± 3.4 points (P < .001 for each), respectively. In addition, 58% of patients achieved clinically significant improvements in ODI, 76% in VAS back pain, and 71% in VAS leg pain. By 1 year, 96.6% of patients and 97.4% of levels were considered fused. There were zero cases of device subsidence and 1 case of device migration (1.7%). There were zero device-related AEs, 1 intraoperative dural tear, and 3 subsequent surgical interventions. CONCLUSIONS: The fusion rate, improvements in patient-reported outcomes, and the AEs observed are consistent with those of other devices. The bidirectional expansion mechanism may provide other important clinical value, but further studies will be required to elucidate the unique advantages. LEVEL OF EVIDENCE: 4.

Closing the Treatment Gap for Lumbar Disc Herniation Patients with Large Annular Defects: A Systematic Review of Techniques and Outcomes in this High-risk Population.

Lumbar disc herniation (LDH) is one of the most common spinal pathologies and can be associated with debilitating pain and neurological dysfunction. Discectomy is the primary surgical intervention for LDH and is typically successful. Yet, some patients experience recurrent LDH (RLDH) after discectomy, which is associated with worse clinical outcomes and greater socioeconomic burden. Large defects in the annulus fibrosis are a significant risk factor for RLDH and present a critical treatment challenge. It is essential to identify reliable and cost-effective treatments for this at-risk population. A systematic review of the PubMed and Embase databases was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to identify studies describing the treatment of LDH patients with large annular defects. The incidence of large annular defects, measurement technique, RLDH rate, and reoperation rate were compiled and stratified by surgical technique. The risk of bias was scored for each study and for the identification of RLDH and reoperation. Study heterogeneity and pooled estimates were calculated from the included articles. Fifteen unique studies describing 2,768 subjects were included. The pooled incidence of patients with a large annular defect was 44%. The pooled incidence of RLDH and reoperation following conventional limited discectomy in this population was 10.6% and 6.0%, respectively. A more aggressive technique, subtotal discectomy, tended to have lower rates of RLDH (5.8%) and reoperation (3.8%). However, patients treated with subtotal discectomy reported greater back and leg pain associated with disc degeneration. The quality of evidence was low for subtotal discectomy as an alternative to limited discectomy. Each report had a high risk of bias and treatments were never randomized. A recent randomized controlled trial with 550 subjects examined an annular closure device (ACD) and observed significant reductions in RLDH and reoperation rates (>50% reduction). Based on the available evidence, current discectomy techniques are inadequate for patients with large annular defects, leaving a treatment gap for this high-risk population. Currently, the strongest evidence indicates that augmenting limited discectomy with an ACD can reduce RLDH and revision rates in patients with large annular defects, with a low risk of device complications.

Adjustable Rigid Interspinous Process Fixation: A Biomechanical Study of Segmental Lordosis and Interbody Loading in the Lumbar Spine.

Background Rigid interspinous process fixation (ISPF) may serve as a minimally disruptive adjunct to lumbar interbody fusion. Previous biomechanical assessments of ISPF have demonstrated particularly advantageous outcomes in stabilizing the sagittal plane. However, ISPF has not been well characterized in regard to its impact on interbody load, which has implications for the risk of cage migration or subsidence, and sagittal alignment. The purpose of this study was to biomechanically assess in vitro the interbody load (IBL), focal lordosis (FL), and spinous process loading generated by in situ compression/distraction with a novel ISPF device capable of incremental in situ shortening/extension. Bilateral pedicle screw fixation (BPSF) was used as a control. Methods Two fresh frozen human lumbar spines were thawed and musculature was removed, leaving ligaments intact. Seven functional spinal units were iteratively tested, which involved a standard lateral discectomy, placement of a modified lateral cage possessing two load cells, and posterior fixation. BPSF and ISPF were performed at each level, with order of fixation was randomized. BPSF was first performed with maximum compressive exertion followed by 75% exertion to represent clinical application. The ISPF device was implanted at a neutral height and incrementally shortened/extended in situ in 1-mm increments. IBL and FL were measured under each condition. Loads on the spinous processes were estimated through bench-top mechanical calibration. Results No significant differences in IBL were observed, but the ISPF device produced a significantly greater change in FL compared to the clinically relevant BPSF compression. IBL, as a function of ISPF device height, expressed linear behavior during compression and exponential behavior during distraction. Conclusions The novel ISPF device produced clinically effective IBL and FL, performing well in comparison to BPSF. Additionally, incremental ISPF device manipulation demonstrated predictable and clinically safe trends regarding loading of the interbody space and spinous processes.

Validated computational framework for efficient systematic evaluation of osteoporotic fracture fixation in the proximal humerus.

The high rate of fixation failure in osteoporotic proximal humerus fractures indicate the need for improved solutions. Computer simulations may help to overcome the limitations of the gold standard biomechanical testing in evaluating the performance of new implants and enhance the effectivity and outcome of the design process. This study presents a framework for automated computational analysis that facilitates efficient and systematic evaluation of proximal humerus fracture plating under a variety of conditions including bone quality, fracture pattern, implant configuration and loading regime. The underlying finite element methodology was previously validated. The capabilities of the software tool are demonstrated by virtually reproducing a previously published biomechanical study on the effect of screw augmentation and showing that the models capture the essence of the experimental results. Due to the modular design of the framework, the currently available set of angle-stable plate implants can be readily expanded to include other fixations such as intramedullary nails. Besides the capability to compare already existing solutions, the tool can provide rapid feedback on novel ideas. Therefore, it is expected to efficiently complement and partially replace expensive experimental tests and aid development and optimization of implant designs for improved fixation of osteoporotic proximal humerus fractures.

Attenuation of Proximal Junctional Kyphosis Using Sublaminar Polyester Tension Bands: A Biomechanical Study.

OBJECTIVE: To investigate the effect of sublaminar polyester tension bands on the biomechanics of the motion segments proximal to a long fusion construct. METHODS: This was a human cadaveric biomechanical study. Pure moments of 4 Nm and 8 Nm were applied to the native spine and the instrumented spine, respectively (n = 8). The test conditions included native spine (T7-L2), fused (T10-L2), fused + bilateral tethers tensioned to 250 N at T9-T10 (tethers 250 N), fused + tethers tensioned to 350 N (tethers 350 N), fused (T11-L2) + tethers tensioned to 250 N at T9-T10 and 350 N at T10-T11 (2-level tethers), fused (T10-L2) + hand-tied suture loop through the spinous processes at T9-T10 (suture loop), and fused (T10-L2) with the T9-T10 interspinous and supraspinous ligaments cut (cut ISL/SSL). RESULTS: The flexion range of motion (ROM) at T9-T10 of the fused spine, loaded at 8 Nm, increased to 162% of the native spine loaded at 4 Nm. The average flexion ROM at T9-T10 for tethers 250 N, tethers 350 N, 2-level tethers, suture loop, and cut ISL/SSL were 85% (P < 0.0001), 70% (P < 0.0001), 93% (P < 0.0001), 141% (P = 0.13), and 177% (P = 0.66) of the native spine at 4 Nm, respectively (P values vs. fused). CONCLUSIONS: Sublaminar polyester bands can modulate the biomechanical flexion ROM as a function of the band pretension and provide a more consistent and tunable technique than hand-tying a suture loop between the spinous processes.

Three dimensional printed calcium phosphate and poly(caprolactone) composites with improved mechanical properties and preserved microstructure.

Biphasic calcium phosphate scaffolds formed via three dimensional (3D) printing technology to exhibit porosity and chemical resorbability to promote osseointegration often lack the strength and toughness required to withstand loading in bone tissue engineering applications. Herein, sintering and CaP:poly(caprolactone) (PCL) composite formation were explored to improve 3D printed scaffold strength and toughness. Hydroxyapatite and α-tricalcium phosphate (α-TCP) biphasic calcium powders were printed using phosphoric acid binder, which generated monetite and hydroxyapatite scaffolds. Upon sintering, evolution of ß-TCP was observed along with an increase in flexural strength and modulus but no effect on fracture toughness was observed. Furthermore, scaffold porosity increased with sintering. Additionally, two techniques of PCL composite formation were employed: postprint precipitation and 3D print codeposition to further augment scaffold mechanical properties. While both techniques significantly improved flexural strength, flexural modulus, and fracture toughness under most conditions explored, precipitation yielded more substantial increases in these properties, which is attributed to better continuity of the PCL phase. However, precipitation also compromised surface porosity due to PCL passivation of the calcium phosphate surface, which may subsequently hinder scaffold integration and bone regeneration. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 106A: 663-672, 2018.

Post-lumbar discectomy reoperations that are associated with poor clinical and socioeconomic outcomes can be reduced through use of a novel annular closure device: results from a 2-year randomized controlled trial.

INTRODUCTION: Lumbar discectomy patients with large annular defects are at a high risk for reherniation and reoperation, which could be mitigated through the use of an annular closure device (ACD). To identify the most effective treatment pathways for this high-risk population, it is critical to understand the clinical outcomes and socioeconomic costs among reoperated patients as well as the utility of ACD for minimizing reoperation risk. METHODS: This was a post hoc analysis of a prospective, multicenter, randomized controlled trial (RCT) designed to investigate the safety and efficacy of an ACD. All 550 patients (both ACD treated and control) from the RCT with follow-up data through 2 years were included in this analysis (69 reoperated and 481 non-reoperated). Reoperations were defined as any revision surgery of the index level, regardless of indication. Equivalent U.S. Medicare expenditures for reoperations were estimated through cost multipliers derived from the commercially available PearlDiver database. RESULTS: A significantly greater number of control patients (45/278; 16%) compared to ACD patients (24/272; 9%) underwent a revision surgery at the index level within 2 years of followup (p=0.01). At 2 years of follow-up, the reoperated patients had significantly worse Oswestry Disability Index scores and visual analog scale for leg and back pain scores compared to their non-reoperated counterparts (p<0.0001). The total estimated direct medical costs for reoperation were US $952,348 ($13,802 per reoperated patient), with control patients accounting for the majority of this cost burden ($565,188; 59%). CONCLUSION: Post-discectomy reoperation is associated with significantly increased patient morbidity, missed work, and direct treatment costs in a population at high risk for reherniation. Annular closure helped minimize this clinical and socioeconomic burden by reducing the incidence of reoperation by nearly 50% (16% control vs 9% ACD).

Fatigue failure of plated osteoporotic proximal humerus fractures is predicted by the strain around the proximal screws.

The high rate of required reoperation indicates that treatment of fragility fractures at the proximal humerus still remains a major challenge in trauma surgery. Improved fixation approaches are needed. Several limitations of the conventional implant development process involving experimental testing could be overcome by using computer models that would allow systematic and efficient analyses. However, such models require experimental validation. This study investigated if linear elastic continuum finite element (FE) models can predict experimental fatigue failure in locking plate fixation of osteoporotic proximal humerus fractures. Three-part fractures were created in twenty fresh-frozen proximal humeri of elderly donors, stabilized with angular stable plate osteosythesis and tested to failure in a previously developed experimental setup using a cyclic loading protocol with increasing peak load. Case-specific, linear elastic FE models of the instrumented samples were created from CT images and loaded virtually by mimicking the experimental conditions. Average principal strains were evaluated in cylindrical regions around the proximal screws. Parametric sensitivity analysis was performed to investigate the effects of specific model parameters on the results. The number of cycles to failure was 10500 ± 3300 (mean ± SD, range: 3100 - 16400) and showed a strong logarithmic correlation with the average compressive principal strain around the screws (R2 = 0.90). These results suggest that the latter parameter may be used as a surrogate estimate for construct stability under cyclic loading. The computationally cheap linear elastic continuum FE analysis could be used as an efficient screening tool for optimization and development of implants. Further work is required to investigate if the findings of this study apply to other loading modes and bone-implant constructs.

New approaches for cement-based prophylactic augmentation of the osteoporotic proximal femur provide enhanced reinforcement as predicted by non-linear finite element simulations.

BACKGROUND: High incidence and increased mortality related to secondary, contralateral proximal femoral fractures may justify invasive prophylactic augmentation that reinforces the osteoporotic proximal femur to reduce fracture risk. Bone cement-based approaches (femoroplasty) may deliver the required strengthening effect; however, the significant variation in the results of previous studies calls for a systematic analysis and optimization of this method. Our hypothesis was that efficient generalized augmentation strategies can be identified via computational optimization. METHODS: This study investigated, by means of finite element analysis, the effect of cement location and volume on the biomechanical properties of fifteen proximal femora in sideways fall. Novel cement cloud locations were developed using the principles of bone remodeling and compared to the "single central" location that was previously reported to be optimal. FINDINGS: The new augmentation strategies provided significantly greater biomechanical benefits compared to the "single central" cement location. Augmenting with approximately 12ml of cement in the newly identified location achieved increases of 11% in stiffness, 64% in yield force, 156% in yield energy and 59% in maximum force, on average, compared to the non-augmented state. The weaker bones experienced a greater biomechanical benefit from augmentation than stronger bones. The effect of cement volume on the biomechanical properties was approximately linear. Results of the "single central" model showed good agreement with previous experimental studies. INTERPRETATION: These findings indicate enhanced potential of cement-based prophylactic augmentation using the newly developed cementing strategy. Future studies should determine the required level of strengthening and confirm these numerical results experimentally.

3D Printing of Calcium Phosphate Ceramics for Bone Tissue Engineering and Drug Delivery.

Additive manufacturing, also known as 3D printing, has emerged over the past 3 decades as a disruptive technology for rapid prototyping and manufacturing. Vat polymerization, powder bed fusion, material extrusion, and binder jetting are distinct technologies of additive manufacturing, which have been used in a wide variety of fields, including biomedical research and tissue engineering. The ability to print biocompatible, patient-specific geometries with controlled macro- and micro-pores, and to incorporate cells, drugs and proteins has made 3D-printing ideal for orthopaedic applications, such as bone grafting. Herein, we performed a systematic review examining the fabrication of calcium phosphate (CaP) ceramics by 3D printing, their biocompatibility in vitro, and their bone regenerative potential in vivo, as well as their use in localized delivery of bioactive molecules or cells. Understanding the advantages and limitations of the different 3D printing approaches, CaP materials, and bioactive additives through critical evaluation of in vitro and in vivo evidence of efficacy is essential for developing new classes of bone graft substitutes that can perform as well as autografts and allografts or even surpass the performance of these clinical standards.

Implicit modeling of screw threads for efficient finite element analysis of complex bone-implant systems.

Finite element analysis is commonly used to assist in the development and evaluation of orthopedic devices. The physics of these models are simplified through approximations that enable more efficient simulations, without compromising the accuracy of the relative comparisons between implant designs or configurations. This study developed and evaluated a technique to approximate the behavior of a finely threaded screw using a smooth cylinder with the threads implicitly represented through interfacial contact conditions. This pseudo-threaded model was calibrated by comparing to simulations that explicitly modeled the thread geometry with frictional contact. A parametric analysis was performed with a single screw-in-bone system, five loading directions, and three Young׳s moduli that span the range of cancellous bone (200, 600, and 1,000MPa). Considering that screw cut-out from cancellous bone is a critical clinical issue in the osteoporotic proximal humerus, the pseudo-threaded model was compared with a bonded interface to examine three different screw configurations in a 3-part proximal humerus fracture across 10 patients. In the single screw-in-bone system, the pseudo-threaded model predicted the screw displacement of the explicitly threaded model with 1-5% difference and estimated the strain distributions and magnitudes more accurately than a bonded interface. Yet, the relative comparisons of implant stability across the three different screw configurations in the proximal humerus were not affected by the modeling choice for the bone-screw interface. Therefore, the bonded interface could serve as a more efficient methodology for making relative comparisons between implants that utilize the same thread profile.

Biomaterials approaches to treating implant-associated osteomyelitis.

Orthopaedic devices are the most common surgical devices associated with implant-related infections and Staphylococcus aureus (S. aureus) is the most common causative pathogen in chronic bone infections (osteomyelitis). Treatment of these chronic bone infections often involves combinations of antibiotics given systemically and locally to the affected site via a biomaterial spacer. The gold standard biomaterial for local antibiotic delivery against osteomyelitis, poly(methyl methacrylate) (PMMA) bone cement, bears many limitations. Such shortcomings include limited antibiotic release, incompatibility with many antimicrobial agents, and the need for follow-up surgeries to remove the non-biodegradable cement before surgical reconstruction of the lost bone. Therefore, extensive research pursuits are targeting alternative, biodegradable materials to replace PMMA in osteomyelitis applications. Herein, we provide an overview of the primary clinical treatment strategies and emerging biodegradable materials that may be employed for management of implant-related osteomyelitis. We performed a systematic review of experimental biomaterials systems that have been evaluated for treating established S. aureus osteomyelitis in an animal model. Many experimental biomaterials were not decisively more efficacious for infection management than PMMA when delivering the same antibiotic. However, alternative biomaterials have reduced the number of follow-up surgeries, enhanced the antimicrobial efficacy by delivering agents that are incompatible with PMMA, and regenerated bone in an infected defect. Understanding the advantages, limitations, and potential for clinical translation of each biomaterial, along with the conditions under which it was evaluated (e.g. animal model), is critical for surgeons and researchers to navigate the plethora of options for local antibiotic delivery.