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AbstractObjectiveTo assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body.DesignRandomised, double blind, sham controlled clinical trial.SettingFour community hospitals in the Netherlands, 2011-15.Participants180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89).InterventionsParticipants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group.Main outcome measuresMain outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months’ follow-up.ResultsThe mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval −0.53 to 0.94) at baseline, −0.43 (−1.17 to 0.31) at one day, −0.11 (−0.85 to 0.63) at one week, 0.41 (−0.33 to 1.15) at one month, 0.21 (−0.54 to 0.96) at three months, 0.39 (−0.37 to 1.15) at six months, and 0.45 (−0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months’ follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction.ConclusionsPercutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months’ follow-up among patients with acute osteoporotic vertebral compression fractures.Trial registrationClinicalTrials.gov NCT01200277.

Treatment of bone defects caused by trauma or disease is a major burden on human healthcare systems. Although autologous bone grafts are considered as the gold standard, they are limited in availability and are associated with post-operative complications. Minimally invasive alternatives using injectable bone cements are currently used in certain clinical procedures, such as vertebroplasty and balloon kyphoplasty. Nevertheless, given the high incidence of fractures and pathologies that result in bone voids, there is an unmet need for injectable materials with desired properties for minimally invasive procedures. This paper provides an overview of the most common injectable bone cement materials for clinical use. The emphasis has been placed on calcium phosphate cements and acrylic bone cements, while enabling the readers to compare the opportunities and challenges for these two classes of bone cements. This paper also briefly reviews antibiotic-loaded bone cements used in bone repair and implant fixation, including their efficacy and cost for healthcare systems. A summary of the current challenges and recommendations for future directions has been brought in the concluding section of this paper.

Osteoporotic bone defect and fracture healing remain significant challenges in clinical practice. While traditional therapeutic approaches provide some regulation of bone homeostasis, they often present limitations and adverse effects. In orthopedic procedures, bone cement serves as a crucial material for stabilizing osteoporotic bone and securing implants. However, with the exception of magnesium phosphate cement, most cement variants lack substantial bone regenerative properties. Recent developments in biomaterial science have opened new avenues for enhancing bone cement functionality through innovative modifications. These advanced materials demonstrate promising capabilities in modulating the bone microenvironment through their distinct physicochemical properties. This review provides a systematic analysis of contemporary biomaterial-based modifications of bone cement, focusing on their influence on the bone healing microenvironment. The discussion begins with an examination of bone microenvironment pathology, followed by an evaluation of various biomaterial modifications and their effects on cement properties. The review then explores regulatory strategies targeting specific microenvironmental elements, including inflammatory response, oxidative stress, osteoblast-osteoclast homeostasis, vascular network formation, and osteocyte-mediated processes. The concluding section addresses current technical challenges and emerging research directions, providing insights for the development of next-generation biomaterials with enhanced functionality and therapeutic potential. Graphical Abstract

Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures. Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466. Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was −5·2 (95% CI −5·88 to −4·72) after vertebroplasty and −2·7 (−3·22 to −1·98) after conservative treatment, and between baseline and 1 year was −5·7 (−6·22 to −4·98) after vertebroplasty and −3·7 (−4·35 to −3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74–3·37, p<0·0001) at 1 month and 2·0 (1·13–2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported. In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost. ZonMw; COOK Medical.

The objective of this study is to fabricate and develop hydroxypropyl methylcellulose (HPMC) hydrogel (HG)-based composite bone cements with incorporation of hydroxyapatite (HA), beta-tricalcium phosphate (β-TCP), and with/without polymethylmethacrylate (PMMA) for vertebroplasty. For animal study, twenty female Wister rats (250–300 g, 12 weeks of age) were divided into four groups including a two non-ovariectomy (NOVX) groups and two ovariectomy (OVX)-induced osteoporosis groups. Two prepared biocomposites including HG/β-TCP/HA and HG/β-TCP/HA/PMMA were injected into the tibial defects of both OVX and NOVX rats for evaluating in vivo osteogenesis after 12 weeks. Micro-computed tomography and histological analysis using hematoxylin and eosin (H&E) and Masson's trichrome stains of the two composite cements implanted into the tibial defects of OVX and NOVX rats revealed enhanced bone regeneration potential. However, no statistically significant differences were noted among the groups based on new bone formation, demonstrating that the injected composite cements showed similar osteogenesis effects in both OVX and NOVX rats. These findings suggest that the newly developed composite bone cement composed of HG, β-TCP, HA and/or PMMA may be a promising and professional tool for treating osteoporotic and non-osteoporotic vertebral fractures.

In this multicenter, randomized trial comparing cemented with modern uncemented hemiarthroplasty in persons 60 years of age or older with an intracapsular hip fracture, cemented hemiarthroplasty resulted in a modestly but significantly better quality of life and a lower risk of periprosthetic fracture than uncemented hemiarthroplasty.

Objectives To verify the clinical significance of the best puncture-side bone cement/vertebral volume ratio (PSBCV/VV%) and bone cement leakage in paravertebral veins during vertebroplasty. Methods This was a retrospective analysis of a total of 210 patients from September 2021 to December 2022, who were divided into an observation group (110 patients) and a control group (100 patients). In the observation group, patients’ preoperative computed tomography (CT) data were imported into Mimics software, and the VV was calculated using the three-dimensional (3D) reconstruction function. Then, based on the best PSBCV/VV% of 13.68% determined in a previous study, the optimal PSBCV to be injected during vertebroplasty was calculated. In the control group, vertebroplasty was performed directly using the conventional method. The incidence of cement leakage into paravertebral veins was observed postoperatively in both groups. Results There were no statistically significant differences (P > 0.05) in the evaluated indicators between the two groups pre- or postoperatively, including the anterior vertebral margin height, mid-vertebral height, injured vertebral Cobb angle, visual analogue scale (VAS) score, and Oswestry Disability Index (ODI). Intragroup comparisons showed improvements in the anterior vertebral height, mid-vertebral height, injured vertebral Cobb angle, VAS score, and ODI after surgery compared with before surgery (P < 0.05). In the observation group, there were 3 cases of cement leakage into the paravertebral veins, for a leakage rate of 2.7%. In the control group, there were 11 cases of cement leakage into the paravertebral veins, for a leakage rate of 11%. The difference in the leakage rate between the two groups was statistically significant (P = 0.016). Conclusion In vertebroplasty, preoperative VV calculations using Mimics software, combined with calculation of the PSBCV according to the best PSBCV/VV% (13.68%), can effectively prevent leakage of bone cement into paravertebral veins and further prevent serious life-threatening complications such as pulmonary embolism.

Background Displaced femoral neck fractures usually are treated with hemiarthroplasty. However, the degree to which the design of the implant used (cemented or uncemented) affects the outcome is not known and may be therapeutically important. Questions/purposes In this randomized controlled trial, we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of (1) Harris hip scores; (2) femoral fractures; (3) overall health outcomes using the Barthel Index and EQ-5D scores; and (4) complications, reoperations, and mortality since our earlier report on this cohort at 1-year followup. Methods We present followup at a median of 5 years after surgery (range, 56–65 months) from a randomized trial comparing a cemented hemiarthroplasty (112 hips) with an uncemented, hydroxyapatite-coated hemiarthroplasty (108 hips), both with a bipolar head. Results were previously reported at 1-year followup. Harris hip scores, Barthel Index, and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon. Complications and reoperations were determined by chart review and radiographs examined by three orthopaedic surgeons. Sixty patients (56%) had died in the cemented group and 63 (60%) in the uncemented group. Respectively, three and two patients (2.7% and 1.9%) were completely lost to followup. Results Harris hip scores at 5 years were higher in the uncemented group than in the cemented group (86.2 versus 76.3; mean difference 9.9; 95% confidence interval [CI], 1.9–17.9). The prevalence of postoperative periprosthetic femoral fractures was 7.4% in the uncemented group and 0.9% in the cemented group (hazard ratio [HR], 9.3; 95% CI, 1.16–74.5). Barthel Index and EQ-5D scores were not different between the groups. Between 1 and 5 years, we found no additional infections or dislocations. The mortality rate was not different between the groups (HR, 1.2; 95% CI, 0.82–1.7). Conclusions Both arthroplasties may be used with good medium-term results after displaced femoral neck fractures. The uncemented hemiarthroplasty may result in higher hip scores but appears to carry an unacceptably high risk of later femoral fractures. Level of Evidence Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

Poly(methyl methacrylate) (PMMA) is widely used in orthopedic applications, including bone cement in total joint replacement surgery, bone fillers, and bone substitutes due to its affordability, biocompatibility, and processability. However, the bone regeneration efficiency of PMMA is limited because of its lack of bioactivity, poor osseointegration, and non-degradability. The use of bone cement also has disadvantages such as methyl methacrylate (MMA) release and high exothermic temperature during the polymerization of PMMA, which can cause thermal necrosis. To address these problems, various strategies have been adopted, such as surface modification techniques and the incorporation of various bioactive agents and biopolymers into PMMA. In this review, the physicochemical properties and synthesis methods of PMMA are discussed, with a special focus on the utilization of various PMMA composites in bone tissue engineering. Additionally, the challenges involved in incorporating PMMA into regenerative medicine are discussed with suitable research findings with the intention of providing insightful advice to support its successful clinical applications.

Background and Objectives: The purpose of this study was to assess the cytotoxicity and antibacterial effects of AgNP-impregnated Tetracalcium phosphate-dicalcium phosphate dihydrate (TTCP-DCPD). Materials and Methods: Using in vitro experiments, the cytotoxicity of AgNP-impregnated TTCP-DCPD against fibroblasts and osteocytes was assessed in terms of cell viability by water-soluble tetrazolium salt assay. To assess antibacterial effects, a disc diffusion test was used; osteomyelitis was induced first in vivo, by injection of methicillin-resistant Staphylococcus aureus into the tibia of rats. AgNP-impregnated TTCP-DCPD bone cement was then applied at various silver concentrations for 3 or 12 weeks. Antibacterial effects were assessed by culturing and reverse transcription-polymerase chain reaction (RT-PCR). For histological observation, the bone tissues were stained using hematoxylin and eosin. Results: Cell viability was decreased by the impregnated bone cement but did not differ according to AgNP concentration. The diameter of the growth-inhibited zone of MRSA was between 4.1 and 13.3 mm on the disks treated with AgNP, indicating antimicrobial effects. In vivo, the numbers of bacterial colonies were reduced in the 12-week treatment groups compared to the 3-week treatment groups. The groups treated with a higher (10×) dose of AgNP (G2–G5) showed a tendency of lower bacterial colony counts compared to the group without AgNP (G1). The PCR analysis results showed a tendency of decreased bacterial gene expression in the AgNP-impregnated TTCP-DCPD groups (G2–G5) compared to the group without AgNP (G1) at 3 and 12 weeks. In the H&E staining, the degree of inflammation and necrosis of the AgNP-impregnated TTCP-DCPD groups (G2–G5) showed a tendency to be lower at 3 and 12 weeks compared to the control group. Our results suggest that AgNP-impregnated TTCP-DCPD cement has antimicrobial effects. Conclusions: This study indicates that AgNP-impregnated TTCP-DCPD bone cement could be considered to treat osteomyelitis.