Vertebral Augmentation Procedures Research Articles

Dual-Fluoroscopy vs. Single-Fluoroscopy in Balloon Kyphoplasty: A Study of Efficiency and Safety.

Background: Vertebral compression fractures (VCFs) are the most prevalent type of osteoporotic fractures, often causing significant pain, morbidity, and mortality. Vertebral augmentation procedures like balloon kyphoplasty (BK) are effective in treating VCFs. These procedures are typically performed using a single fluoroscopy machine (SF) for anteroposterior (AP) and lateral views. We have implemented a dual-fluoroscopy (DF) technique to reduce procedure time and radiation exposure. The goal of this study was to determine whether dual-fluoroscopy could optimize surgical efficiency without compromising safety, offering a more effective alternative to traditional single-fluoroscopy methods. Methods: This retrospective study included 126 patients who underwent BK with either SF (n = 74, 58.7%) or DF (n = 52, 41.3%) between 2020 and 2024. We collected data on procedure duration per pedicle (PDPP), radiation exposure (reference air kerma and dose-area product [DAP]), and radiation duration. A sub-analysis of post-learning phase cases was performed. Results: A learning curve was identified for the first 24 cases and 15 cases using the SF technique and DF technique, respectively, which was followed by a stabilization in procedure duration per pedicle (Levene's statistic = 10.623, p = 0.002 for SD difference, p < 0.001 for mean PDPP difference). After the completion of the learning phase for both techniques, the DF group demonstrated a significantly shorter PDPP (11.83 ± 4.3 vs. 14.03 ± 5.57 min, p = 0.049). No significant differences were found in radiation exposure, including radiation duration (p = 0.577), reference air kerma, or DAP. Conclusions: Dual-fluoroscopy significantly reduces procedure time after the learning curve is overcome, improving efficiency without increasing radiation exposure. This technique holds promise for optimizing kyphoplasty workflow and safety, supporting broader clinical adoption.

Cement Leakage after Augmentation of Osteoporotic Vertebral Bodies.

Cement leakage is the most common complication of vertebral cement augmentation. The present study investigated cement leakage rates in spinal cement augmentation procedures and identified potential risk factors for cement leakage.140 cases (258 vertebrae) in 131 consecutive patients and nine postmortem cases were evaluated. A total of 258 cement-augmented vertebrae were studied. The data for this were obtained from the hospital records of 131 patients who underwent such operations in 2 orthopaedic trauma surgery clinics in the FRG and from the examinations of 9 postmortem cases at the Institute of Forensic Medicine of the University Medical Centre Hamburg-Eppendorf.Cement leaks were identified in 64 of the 140 cases (45.7%). Local cement leaks were the most common type of leak, accounting for 73.4% of leaks (n=47). Venous leaks were evaluated in 15 cases (23.4%) and pulmonary embolisations in 2 cases (3.1%). Within the group of retrospectively studied cases (n=131), only one patient (0.8%) suffered a symptomatic cement leak. Cement augmentation of fractures to lumbar vertebrae and application of large doses of cement were identified as risk factors for cement leakage.Both the data in the literature relevant to the topic and the results of this work demonstrate a high incidence of cement leakage after vertebral body augmentation procedures. Risk factors for cement leakage are described. Despite the low percentage of symptomatic cases, the possible factors influencing cement leakage should be considered and included in the surgical planning when planning and performing cement augmentations on vertebral bodies.

Vertebroplasty and kyphoplasty in the management of osteoporotic vertebral compression fractures in elderly individuals: evaluation of the health-related quality of life.

Aim of this study is to investigate the safety, efficacy and impact on Health-Related Quality of Life (HRQoL) of Vertebroplasty (VP) and Kyphoplasty (KP) in the management of Osteoporotic Vertebral Compression Fractures (OVCFs) in elderly individuals. VP and KP represent Minimally Invasive Vertebral Augmentation (MIVA) procedures that are increasingly implemented for surgical treatment of OVCFs in recent years. These interventions have been associated with minimal traumatization and intraoperative hemorrhage, considerable analgesic effect and rapid postoperative recovery. Seventy-seven (77) consecutive individuals with OVCFs were subjected to VP/KP and recruited in this prospectively designed non-randomized study. Clinical evaluation was performed preoperatively and postoperatively at particular chronic intervals at 1, 6 weeks and at 3, 6, 12 months and 2 years. Assessment was conducted via the standardized Visual Analogue Scale (VAS) and Short-Form 36 (SF-36) Medical Health Survey Questionnaire for pain and HRQoL, respectively. No perioperative complications were observed. All studied indices were demonstrated to present a statistically significant amelioration following overall analysis. Pain intensity measured by the VAS score was depicted to be significantly reduced during the first 3 months, but continuous improvement of all indices of SF-36 and VAS was demonstrated to reach a plateau at 6 months, featuring no further clinical improvement.VP and KP represent safe and efficient options for interventional treatment of OVCFs in elderly and oldest-old patients, improving self-reported symptoms of pain as well as overall HRQoL.

Osteoporotic vertebral fracture: Our Experience and update

Introduction: Osteoporotic vertebral fracture is a fragility fracture due to osteoporosis and is a growing public health problem. It mainly affects postmenopausal women and men &gt; 50 years. It significantly affects morbidity, financial condition, quality of life and mortality of patients. It presents mainly with back pain, which is mostly manageable with conservative measures. Those with unrelieved pain, severe spinal deformity or neurological impairment would require intervention. The quality of bone and surgical fitness along with associated co-morbidities of these elderly people, require special consideration, indications and appropriate modification of technique and instruments for surgical intervention. Materials and methodology: This prospective study summarizes the management of osteoporotic vertebral fractures from September 2015 to September 2021 in Nepal Medical College, Kathmandu, Nepal. The study included patients with back pain of more than 50 years old age. The backpain was evaluated clinically using visual analogue scale and Oswestry Disability Index, neurological deficits using Frankel grading system and deformity using X-ray. Other investigations included MRI, Dexa scan, Serum calcium and Vitamin D3. Risk factors for developing osteoporosis and OVF were also assessed. Results: Out of the 630 patients of more than 50 years age, presenting in neurosurgical OPD with backache from September 2015 to September 2020, 158 cases were later diagnosed to have osteoporotic spine fractures. There were 122 (77.2%) postmenopausal ladies and 36 (22.8%) gentlemen. All had backpain, with 36% having VAS score of &lt; 3 and 64% had ODI of mild to moderate disability. The neurological deficits were present in 16.4% and mostly were Frankel grade C and D. Significant kyphoscoliosis (Cobb angle more than 20 degrees) in X-ray was present in 18 (11.3%) patients. 88 (55.7%) patients had Dexa scan and T score was less than -2.5 in 88 (56%). Serum calcium was low in (41) 26% and Vitamin D3 was low in (107) 67.7% of the patients. For backpain, all were started on non-operative management. Vertebral augmentation procedure was not available in our institute. Thus, surgery was offered in 44 (28%) of the patients but only 18 (11.4%) agreed for surgery and underwent decompression with long segment fixation. Only 48 patients remained in follow up for more than 2 years and all had satisfactory control of pain with no deterioration in deformity or neurological deficit. There were no significant short or long-term complications or mortality. Conclusion: Osteoporotic vertebral fracture is a very common reason for back pain in people of more than 50 years old affecting their livelihood. The majority responded to conservative treatment. Those indicated for surgery need special consideration in preparation, technique and devices. Preventive measures can help reduce the problem load.

The Role of Vertebral Augmentation Procedures in the Management of Multiple Myeloma.

Approximately 90% of patients with multiple myeloma experience significant pain from osseous involvement during their lifetime. Untreated osseous involvement results in vertebral compression fractures, leading to negative consequences for quality of life. Vertebral augmentation procedures, including percutaneous vertebroplasty and kyphoplasty, offer better and faster pain control and likely lower morbidity compared with non-operative interventions. Our review provides an up-to-date summary of the indications, contraindications, timing, outcomes, and potential complications of vertebral augmentation procedures to guide practicing oncologists in effectively managing bone disease in patients with multiple myeloma.

Vertebral compression fractures: pain relief, progression and new fracture rate comparing vertebral augmentation with brace

BackgroundOsteoporotic vertebral compression fracture (VCF) is the third most frequent fragility fracture in the world. Conservative treatment, vertebroplasty, and kyphoplasty are all recognized therapies. However, diagnostic and therapeutic recommendations must be more consistent when comparing clinical guidelines. This study aims to compare the efficacy of vertebral augmentation therapy and conservative management for treating VCFs, the risk of subsequent complications, and the length of hospital stay.MethodAll patients over 50 years old with a diagnosis of thoracic or lumbar VCF without underlying oncological process, treated conservatively or surgically, and consecutively attended at our department from January 2017 to June 2021 were retrospectively selected for analysis. Patients who missed follow-up or died during the first three months were excluded.ResultsA total of 573 cases were selected for analysis. Most patients were treated conservatively (85.3%). Both groups were homogenous regarding epidemiological and clinical features. The median time elapsed to achieve pain relief was significantly lower in the surgical cohort (4.5 vs. 10 weeks, p < 0.001), and the proportion of patients reporting pain at the first outpatient visit was also significantly lower with a vertebral augmentation procedure (p = 0.004). The new fracture rate and the adjacent level rate did not differ significantly when comparing both treatments, whereas the progression of the diagnosed fracture was more frequent in the conservative group (4.8% vs. 29.7%; p < 0.001). The median hospital stay was significantly lower in the conservative group (3 vs. 10 days; p < 0.001).ConclusionSurgical treatment (vertebroplasty/kyphoplasty) of VCFs was associated with sooner pain relief without an increased risk of new or adjacent fractures. Moreover, the progression of treated fractures was significantly lower in the surgical cohort. The only unfavorable aspect was the more extended hospital stay compared with the conservative treatment group.

Preoperative Prediction of New Vertebral Fractures after Vertebral Augmentation with a Radiomics Nomogram.

The occurrence of new vertebral fractures (NVFs) after vertebral augmentation (VA) procedures is common in patients with osteoporotic vertebral compression fractures (OVCFs), leading to painful experiences and financial burdens. We aim to develop a radiomics nomogram for the preoperative prediction of NVFs after VA. Data from center 1 (training set: n = 153; internal validation set: n = 66) and center 2 (external validation set: n = 44) were retrospectively collected. Radiomics features were extracted from MRI images and radiomics scores (radscores) were constructed for each level-specific vertebra based on least absolute shrinkage and selection operator (LASSO). The radiomics nomogram, integrating radiomics signature with presence of intravertebral cleft and number of previous vertebral fractures, was developed by multivariable logistic regression analysis. The predictive performance of the vertebrae was level-specific based on radscores and was generally superior to clinical variables. RadscoreL2 had the optimal discrimination (AUC ≥ 0.751). The nomogram provided good predictive performance (AUC ≥ 0.834), favorable calibration, and large clinical net benefits in each set. It was used successfully to categorize patients into high- or low-risk subgroups. As a noninvasive preoperative prediction tool, the MRI-based radiomics nomogram holds great promise for individualized prediction of NVFs following VA.

Cost-effectiveness and willing-to-pay thresholds for vertebral augmentation of osteoporotic vertebral fractures, what are they based on: a systematic review

ObjectiveAlthough there is substantial clinical evidence on the safety and effectiveness of vertebral augmentation for osteoporotic vertebral fractures, cost-effectiveness is less well known. The objective of this study is to...

Development and validation of a machine learning model to predict imminent new vertebral fractures after vertebral augmentation

BackgroundAccurately predicting the occurrence of imminent new vertebral fractures (NVFs) in patients with osteoporotic vertebral compression fractures (OVCFs) undergoing vertebral augmentation (VA) is challenging with yet no effective approach. This study aim to examine a machine learning model based on radiomics signature and clinical factors in predicting imminent new vertebral fractures after vertebral augmentation.MethodsA total of 235 eligible patients with OVCFs who underwent VA procedures were recruited from two independent institutions and categorized into three groups, including training set (n = 138), internal validation set (n = 59), and external validation set (n = 38). In the training set, radiomics features were computationally retrieved from L1 or adjacent vertebral body (T12 or L2) on T1-w MRI images, and a radiomics signature was constructed using the least absolute shrinkage and selection operator algorithm (LASSO). Predictive radiomics signature and clinical factors were fitted into two final prediction models using the random survival forest (RSF) algorithm or COX proportional hazard (CPH) analysis. Independent internal and external validation sets were used to validate the prediction models.ResultsThe two prediction models were integrated with radiomics signature and intravertebral cleft (IVC). The RSF model with C-indices of 0.763, 0.773, and 0.731 and time-dependent AUC (2 years) of 0.855, 0.907, and 0.839 (p < 0.001 for all) was found to be better predictive than the CPH model in training, internal and external validation sets. The RSF model provided better calibration, larger net benefits (determined by decision curve analysis), and lower prediction error (time-dependent brier score of 0.156, 0.151, and 0.146, respectively) than the CPH model.ConclusionsThe integrated RSF model showed the potential to predict imminent NVFs following vertebral augmentation, which will aid in postoperative follow-up and treatment.

Early cement augmentation may be a good treatment option for pain relief for osteoporotic compression fractures: a systematic review and meta-analysis.

The incidence of osteoporotic compression fractures (VCFs) have been rising over the past decades. Presently, vertebral cement augmentation procedures such as balloon kyphoplasty and vertebroplasty are common treatments allowing pain relief and functional recovery. However, there is controversy on whether different timeframes for cement augmentation affects clinical outcomes. Hence, this study aimed to compare pain relief and complication rates between early versus late cement augmentation. A comprehensive systematic review of PubMed, EMBASE, Scopus and Cochrane Library was conducted, identifying studies that compared early versus late cement augmentation for VCFs. As the definitions of "early" and "late" phases across studies are heterogenous, we established the cut-off between early and late phase as intervals to accommodate as many studies as possible for analysis. We conducted two separate analyses with different cut-off intervals and included studies that reported interventions within these respective time intervals. In analysis 1, we included studies which grouped patients into "early" and "late" group based on a cut-off time frame of 2-4weeks. On the other hand, in analysis 2, we included studies which grouped patients into "early" and "late" groups based on a cut-off time frame of 6-8weeks. Meta-analysis was conducted via random-effect models, comparing outcomes of interest between early and late groups. Eleven studies were included. The total cohort size was 712 and 775 patients in analysis 1 and 2 respectively. Mean follow-up was 12.9 ± 3.7months and 11 ± 0.6months respectively. VAS change at final follow-up was significantly greater in the early group for both analyses. (MD = - 0.66, p = 0.01; and MD = - 1.18, p < 0.005 respectively). There was no significant difference in post-operative absolute VAS score, number of cement leakage, number of adjacent compression fractures and local kyphotic angle, for both analyses. Patients in both groups experienced reductions in VAS score that exceeded the minimum clinically important difference. Both early and late timeframes for cement augmentation offered significant improvement in pain relief, with similar post-operative absolute pain score, kyphotic angle, cement leakage and adjacent vertebral fractures. Early surgery may offer substantial pain relief in patients presenting with pain as early as < 2-4weeks of VCFs.

Percutaneous vertebroplasty: efficacy in the management of pain related to acute vertebral compression fractures.

Historically, both acute and chronic vertebral compression fractures (VCF) have been managed with vertebral augmentation procedures such as percutaneous vertebroplasty (VP). Recently, however, the trend has shifted to manage VCF pharmacotherapeutically. This study aims to determine if VP is effective for managing pain related to acute VCF (≤12 weeks). This study retrospectively surveyed 8 of 15 patients that underwent VP at Middlemore Hospital between 2018 and 2021. All had VCF aged ≤12 weeks, and presence of increased bone marrow signal on magnetic resonance imaging (MRI). The survey reviewed pain levels (via numeric score), opiate analgesia dispensation, and mobility levels pre- and post-procedure. Results showed post-procedure improvement in pain levels in 75% of individuals, which were maintained over the two- and four-week marks. There was an improvement in mobility in 75% of patients at 4 weeks, and 66% had decreased dispensation or complete cessation of opioid analgesia 4 weeks post procedure. This study shows that VP correlates with overall improvement in pain scores, opiate use and mobility in the sample group with VCF aged ≤12 weeks. Hopefully the results of this study will encourage physicians to consider vertebroplasty as a method of achieving adequate analgesia in this demographic of patients.

Evaluation of the role of vertebral augmentation in chronic vertebral compression fractures: A retrospective study

ObjectivesVertebral augmentation is recommended for acute or subacute vertebral compression fractures (VCFs); few studies claim its usefulness in chronic VCFs also. Use of radionuclide imaging may improvise identification of chronic VCFs that may benefit from vertebral augmentation; hence we have evaluated efficacy of vertebral augmentation procedures in chronic VCFs with incomplete fracture healing suggested either by MRI or Tc99m- MDP bone scan. Materials and MethodsPatients with chronic osteoporotic VCFs (>12 weeks) during the period of June 2013 to June 2019 were included in this retrospective study; patients with evidence of incomplete fracture healing either by MRI or bone scan imaging with Tc 99m-MDP underwent vertebroplasty or kyphoplasty. Primary outcome measure was patient’s pain score measured by numerical rating scale (NRS); secondary outcome measures were patient’s disability assessed by Roland Morris Disability questionnaire (RDQ); quality of life assessed by Quality of life questionnaire of European Foundation of Osteoporosis (QUALLEFO) and analgesic usage. P ​< ​0.050 was considered as significant. Results34 patients were enrolled for the study with median fracture age of 36 months. The median NRS pain scores, RDQ scores, QUALEFFO scores and analgesic usage were significantly reduced at all-time points as compared to the baseline value over the follow up period of 1 year after vertebral augmentation procedure (P ​< ​0.050). Cement leakage was seen in 5 patients (15%). ConclusionVertebral augmentation procedures provided significant improvements in pain scores, disability and quality of life in patients of chronic osteoporotic VCFs with median fracture age of 36 months.

The role of Vertebral Augmentation Procedures in the management of vertebral compression fractures secondary to multiple myeloma.

Multiple myeloma (MM) is a systemic disorder characterised by proliferation of B-lymphocytes and plasma cells in the bone marrow. The primary aims of the management of spinal lesions in MM are pain control and fracture stabilisation. Vertebral augmentation procedures (VAP) can be subdivided into percutaneous vertebroplasty (VP) and balloon kyphoplasty (BKP). BKP involves the placement of orthopaedic balloons into the fractured vertebral body, creating a void into which polymethylmethacrylate bone cement is injected. This review outlines the management of spinal lesions in patients with MM, with a focus on the comparative risks and efficacy of vertebroplasty (VP) and balloon kyphoplasty (BKP). Soft tissue masses in MM are highly radiosensitive. Bisphosphonates and newer oncological therapies have decreased the indications for palliative radiotherapy, while spinal bracing can be utilised in selected cases to provide stability. BKP and VP provide equivalent long term pain control after MM vertebral compression fractures (VCF). BKP is superior to non-operative management and VP for restoration of vertebral body height and prevention of segmental kyphosis. Current evidence suggests a greater degree of correction of kyphotic deformity and restoration of mid vertebral height (MVH) with BKP when compared with VP. The literature supports the use of BKP even in the presence of posterior vertebral body wall (PVBW) fractures, a group previously considered a contraindication to VAP. Superior functional outcomes have been reported in patients undergoing early versus delayed BKP (<6-8weeks). Current evidence supports a lower risk of cement extrusion with BKP than with VP, but serious complications following VAP are rare. MM spinal pathology should be managed in a multidisciplinary setting. Surgical decompression and instrumentation are rarely indicated, due to the radio-sensitivity of soft tissue lesions in MM. BKP is a safe and effective procedure for VCF secondary to MM.

Prognostic Analysis of Spinal Metastasis Secondary to Lung Cancer after Surgeries: A Unicentric, Large-Cohort, Retrospective Study.

Spinal metastases of lung cancer (SMLC) usually have high degree of malignancy and require surgical treatment. However, there are several controversies about the efficacy of surgery. This study aimed to investigate factors predicting prognosis of SMLC after surgery-based comprehensive treatment. A cohort of 112 cases of SMLC who underwent surgical treatment between 2009 and 2020 were retrospectively reviewed and analyzed. The surgical strategies included total en-bloc spondylectomy, debulking surgery, palliative decompression, and vertebral augmentation procedures. The patients were regularly followed-up. Survival analysis was performed, as well as analysis of the patients' neurological recovery, pain relief, and improvement of Karnosky performance score (KPS). Cox regression was used to analyze influencing factors of survival time, and Kaplan-Meier method was performed in survival analysis. The cohort included 63 males and 49 females, with an average age of 60.6 ± 10.6 years. Median survival time was 16months. A total of 86.7% of paralysis patients' neurological function recovered and 83.9% of patients with low KPS score (10-40) improved. Surgical method was significantly correlated with improvement of neurological function (p < 0.001) and KPS (p < 0.001). The mean bleeding volume was 502 ml and operative time was 170 min. The survival rates at 3, 6, 12, 24, and 36months were 92.0%, 80.4%, 63.4%, 63.4%, and 22.6%, respectively. Postoperative Frankel grade (p < 0.001), postoperative KPS score (p=0.001), and application of molecular targeted drugs (p < 0.001) were significantly correlated with survival time in univariate analysis, while application of molecular targeted drugs was an independent predictor for a longer survival by a multivariate analysis. Surgery-based comprehensive treatment brought a fair outcome, with elongated survival time. Surgery can significantly improve patients' neurological function and physical performance status. Adjuvant targeted therapy is an independent positive factor for patients' survival.

Three generations of treatments for osteoporotic vertebral fractures: what is the evidence?

The management of vertebral compression fractures (VCFs) is based on conservative treatment and minimally invasive vertebral augmentation procedures. However, the role of vertebral augmentation is now being questioned by clinical trials and extensive studies. The aim of this review is to report the most relevant evidences on effectiveness, safety, and indications of the currently available vertebral augmentation techniques. Conservative treatment with bracing is effective in reducing acute but it has no effect on segmental kyphosis progression and pseudoarthrosis can occur. Percutaneous vertebroplasty (PV) was the first vertebral augmentation technique to be proposed for the treatment of VCFs. Two blinded and randomized clinical trials compared PV to a sham procedure and no significant differences in terms of efficacy were reported. More recent studies have suggested that PV can still benefit patients with acute VCFs and severe pain at onset. Balloon kyphoplasty (BK) was developed to improve the segmental alignment restoring the height of collapsed vertebrae. BK allows similar pain relief and disability improvement, as well as greater kyphosis correction compared to PV, moreover BKP seems to reduce cement leakage. Vertebral body stenting (VBS) and the KIVA system are third generation techniques of vertebral augmentation. VBS aims to increase the effectiveness in restoring the segmental alignment, while the KIVA system can prevent cement leakage. These techniques are effective and safe, even if their superiority to BK has yet to be proven by studies with a high level of evidence.

Vertebral augmentation in osteoporotic spine fractures: WFNS Spine Committee recommendations.

The aim of this study was to formulate the WFNS Spine Committee guidelines on indications, outcomes, and complications of vertebral augmentation in osteoporotic spine fractures. Computerized literature was searched from 2010 to 2021 using keywords "vertebral augmentation," "osteoporotic fracture," "technique," "surgery," "complication," and "outcome." PubMed yielded 92 articles whereas Google scholar resulted in 120 articles. 29 articles were studied in detail. The studies comprised of seventeen RCT's, two prospective non-randomized studies, three retrospective studies, and seven systematic reviews. The statements were produced to reach a consensus in two separate meetings of WFNS Spine Committee. The statements were voted and reached a positive or negative consensus using Delphi method. Drafted statements on "Vertebral Augmentation in osteoporotic Spine Fractures" were voted upon by expert panelists in Virtual WFNS Spine Committee Consensus Meetings conducted on January 11, 2021, and February 13, 2021. Statements reaching positive consensus provided the basis for the WFNS guidelines regarding vertebral augmentation in osteoporotic spine fractures. WFNS Spine Committee recommendations on vertebral augmentation in osteoporotic spine fractures are summarized in this article. Vertebral augmentation is superior to conservative treatment for vertebral osteoporotic fractures but has conflicting results on comparison with placebo. Both vertebroplasty and kyphoplasty are equally effective. Most of the studies regarding the efficacy of vertebral augmentation procedures to reduce pain have been largely inconclusive. It is suggested that further high quality, better designed randomized controlled studies are required to establish the role of vertebral augmentation in spine osteoporotic compression fractures.

Efficacy of Recombinant Human Parathyroid Hormone versus Vertebral Augmentation Procedure on Patients with Acute Osteoporotic Vertebral Compression Fracture.

ObjectiveAlthough widely used in clinical practice, vertebral augmentation procedure (VAP) for osteoporotic vertebral compression fracture (OVCF) is not supported. Recently, the effect of recombinant human parathyroid hormone (1–34) (rhPTH) has been paid great attention for its efficacy in anti‐osteoporosis and bone union. This study aims to explore the outcome of rhPTH on acute OVCF and compare it with VAP to clarify its therapeutic advantages.MethodsThe retrospective study comprised 71 acute OVCF patients from January 2015 to March 2020: 22 received rhPTH treatment (rhPTH group) and 49 underwent VAP (VAP group). The rhPTH group was 15 women and seven men with an average of 76.18 years, and the VAP group were 35 women and 14 men with an average of 73.63 years. The thoracic/lumbar vertebrae were 14/8 in the rhPTH group and 29/20 in the VAP group. The average follow‐up period was 14.05 months in the rhPTH group and 13.82 months in the VAP group. The two groups were assessed regarding the visual analog score (VAS), Oswestry Disability Index (ODI), OVCF bone union, bone mineral density (BMD), kyphotic angle (KA), anterior and posterior border height (ABH and PBH, respectively), adverse events and the health‐related quality of life assessed by short form‐36 health survey scores (SF‐36). Categorical variables were analyzed by chi‐square test and continuous variables between groups were analyzed by independent samples t‐test or Mann–Whitney U test according to the normality.ResultsDuring the follow‐up, the VAS was significantly lower in the rhPTH group than in the VAP group at month 3 (0.39 ± 0.6 vs 0.68 ± 0.651) (p = 0.047), month 6 (0.45 ± 0.60 vs 2.18 ± 1.22) (p < 0.001), and month 12 (0.45 ± 0.60 vs 2.43 ± 1.49) (p < 0.001). At month 12, the ODI was significantly lower in the rhPTH group (18.59 ± 3.33%) than in the VAP group (28.93 ± 16.71%) (p < 0.001). Bone bridge was detected on sagittal computed tomography images of all fractured vertebrae in the rhPTH group. The BMD was significantly higher in the rhPTH group (87.66 ± 5.91 Hounsfield units [HU]) than in the VAP group (68.15 ± 11.32HU) (p < 0.001). There were no significant differences in the changes in KA, ABH, and PBH between groups (all p > 0.05). The incidence of new OVCF was significantly lower in the rhPTH group than in the VAP group (p = 0.042). All scores of SF‐36 were significantly higher in the rhPTH group than in the VAP group (all p < 0.05).ConclusionIn acute OVCF patients, rhPTH was better than VAP in increasing spinal BMD to promote OVCF healing, reduce new OVCF, and improve back pain, physical ability, and health‐related quality of life.

195. A comparison of mortality following vertebral compression fractures in patients with or without vertebral augmentation

<h3>BACKGROUND CONTEXT</h3> With advancing age, there is a natural diminution of bone density. Aging is also associated with the development of other chronic medical conditions. The expected loss of bone density in aging patients brings an increased frequency of vertebral compression fractures; when combined with an increased presence of multiple comorbid conditions, these patients may be at a higher risk of mortality and morbidity following a compression fracture. One of the mechanisms of this is worsening physiological deconditioning that may be associated from the loss of mobility secondary to pain from a new fracture. Vertebral augmentation, such as balloon kyphoplasty, is performed to relieve pain in this patient cohort. With a reduction in pain, there is the expectation that patients may regain a degree of function and mobility, and thus avoid the risks associated with debility in elderly patients with various chronic medical conditions. <h3>PURPOSE</h3> The purpose of this study was thus to retrospectively evaluate patients who had sustained vertebral compression fractures, with the intent of comparing mortality rates in those with or without vertebral augmentation. <h3>STUDY DESIGN/SETTING</h3> This was a retrospective chart review of consecutive patients over a 5-year period. The study was performed at a Level I trauma center. <h3>PATIENT SAMPLE</h3> A cohort of 2,829 patients were included, this was based on diagnosis codes for vertebral compression fractures, and a subgroup of 110 patients who has received vertebral augmentation, based on procedures codes was extracted from within the initial cohort. <h3>OUTCOME MEASURES</h3> Presence of compression fracture, presence of vertebral augmentation procedure, mortality. <h3>METHODS</h3> Following approval from the local Institutional Review Board, consecutive patients who sustained vertebral compression fractures between the 5-year period between 01/01/2015 to 12/31/2019 were identified using diagnosis codes. These patients were then further stratified based on procedure codes to determine whether or not they had vertebral augmentation. A univariate analysis will be performed to examine quantitative variables using central tendency and variation. Qualitative variables will be examined by frequencies and counts. Variables collected will also be descriptively analyzed by time and measures of association will be analyzed between variable pairings. The primary outcome of mortality will be investigated between two cohorts by a Chi-square test or Fisher's Exact test. A survival analysis may be performed to analyze significant differences between cohorts. All tests will be two-sided where appropriate with an alpha of 0.05 to determine statistical significance. Results will also be presented graphically when appropriate. <h3>RESULTS</h3> The study population was composed of 1,406 (49.70%) females and 1,423 (50.30%) males. Comparing the mortality between patients that received a kyphoplasty or not, a statistically significant association was found where 21.82% of patients that received a kyphoplasty were deceased and 13.68% of patients that did not receive a kyphoplasty were deceased (p=0.0159). The mean age in years of 110 kyphoplasty patients was 71.65 (95% CI 69.40-73.89). A survival analysis was conducted to test the equality of mortality estimates between subjects that received a kyphoplasty or not. No significant differences were found between the strata of survival between both groups using a log-rank test of equality (p=0.7138) Fracture type and mortality's associations with comorbidities were examined by chi-square and Fisher's-exact statistics. Significant associations were found between mortality and diabetes (p=0.0145) and renal disease (p=0.0036). Frequencies and percentages for each association examined can be observed in the excel attachment. <h3>CONCLUSIONS</h3> One of the most striking features of this cohort was the relatively small proportions of patients having augmentation procedures. Patients with compression fractures vary, and there may be a degree of self-selection, as the amount of pain and debility varies; those who remain functional, and presumably in a better state of health despite a fracture (will frequently not even be aware of the presence of a fracture), will likely not undergo a vertebral augmentation. Also surprising was the fact that mortality was greater in the procedure group, although the intrinsic differences in the patient groups would account for this. The presence of comorbid conditions was associated with a heightened risk of mortality, specifically in patients with diabetes and renal disease. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Analysis of Vertebral Augmentation Procedures from 2010 to 2018: Sequela of Controversy from Randomized Control Trials and Guidelines

Analysis of Vertebral Augmentation Procedures from 2010 to 2018: Sequela of Controversy from Randomized Control Trials and Guidelines

364 A Novel Preparation of Bone Cement for Vertebroplasty: Can Strontium Folate Improve the Mechanical and Biological Properties of Calcium Phosphate Cement?

Abstract Aim Bone cements currently used for vertebral body augmentation procedures lack biological properties that allow them to osseointegrate. Strontium folate (SrFo) has been shown to increase the viability of human osteoblast (HOb) cells. The potential of a novel preparation of calcium phosphate cement (CPC) with added SrFo is explored to investigate whether SrFo can increase its biocompatibility. Method Brushite-forming CPCs with 0% (negative control) and 5% and 10% weight-weight additions of SrR (positive control) and SrFo were formulated. Initial (Ti) and final (Tf) setting times were measured. Mechanical analyses included ultimate compressive strength and plane strain fracture toughness. Topography and distribution analyses occurred during materials characterisation and in vitro analysis using scanning electron microscopy (SEM). Results There was no significant difference in the Ti between the CPCs, but significantly greater Tf for all SrFo-CPCs. There was no significant difference in the compressive strength between the CPCs, but a significantly decreased fracture toughness in all SrFo-CPCs. SEM revealed non-homogeneous structures in all SrFo-CPCs. Whilst the pH of the HOb cell culture medium remained the same for all CPCs, the proportion of dead cells was significantly higher than that of alive cells. Conclusions The addition of SrFo did not produce any significant differences in the material characteristics of the cements, nor the in vitro properties, except for a prolonged setting time. Future studies should seek to determine the osteogenic nature of SrFo by altering the formulation of the CPCs to a non-toxic preparation, such as apatite-forming cements which are known to have superior mechanical properties.