Anterior thoracolumbar column reconstruction with the vertebral body stent—safety and efficacy

Purpose

The aim of this study was to assess safety and efficacy of vertebral body stenting (VBS) by analyzing (1) radiographic outcome, (2) clinical outcome, and (3) perioperative complications in patients with vertebral compression fractures treated with VBS at minimum 6-month follow-up.

Methods

In this retrospective cohort study, 78 patients (61 ± 14 [21–90] years; 67% female) who have received a vertebral body stent due to a traumatic, osteoporotic or metastatic thoracolumbar compression fracture at our hospital between 2012 and 2020 were included. Median follow-up was 0.9 years with a minimum follow-up of 6 months. Radiographic and clinical outcome was analyzed directly, 6 weeks, 12 weeks, 6 months postoperatively, and at last follow-up.

Results

Anterior vertebral body height of all patients improved significantly by mean 6.2 ± 4.8 mm directly postoperatively (p < 0.0001) and remained at 4.3 ± 5.1 mm at last follow-up compared to preoperatively (p < 0.0001). The fracture kyphosis angle of all patients improved significantly by mean 5.8 ± 6.9 degrees directly postoperatively (p < 0.0001) and remained at mean 4.9 ± 6.9 degrees at last follow-up compared to preoperatively (p < 0.0001). The segmental kyphosis angle of all patients improved significantly by mean 7.1 ± 7.6 degrees directly postoperatively (p < 0.0001) and remained at mean 2.8 ± 7.8 degrees at last follow-up compared to preoperatively (p = 0.03). Back pain was ameliorated from a preoperative median Numeric Rating Scale value of 6.5 to 3.0 directly postoperatively and further bettered to 1.0 six months postoperatively (p = 0.0001). Revision surgery was required in one patient after 0.4 years.

Conclusion

Vertebral body stenting is a safe and effective treatment option for osteoporotic, traumatic and metastatic compression fractures.

     

A meta-analysis of the effect of strontium ranelate on the risk of vertebral and non-vertebral fracture in postmenopausal osteoporosis and the interaction with FRAX?

Summary  

The aim of the present study was to determine the efficacy of strontium ranelate as a function of baseline fracture risk. Treatment with strontium ranelate was associated with a significant 31% decrease in all clinical osteoporotic fractures (vertebral fractures included). Hazard ratios for the effect of strontium ranelate on the fracture outcome did not change significantly with increasing fracture probability.     

Comparative study on CT and MRI in diagnosis of vertebral burst fracture

Objective:To evaluate the dignostic value of CT and MRI in diagnosis and directing management of vertebral burstfractures. Methods: The imaging features of 66 cases of vertebral burst fracture were retrospectively analyzed, including cervicalvertebrae in 6, thoracic vertebrae in 3, thoracolumbar area in 48 and lumbar vertebrae in 9 cases; 50 male and 16 female; withan average age of 35 years. CT and MRI were done in all patients. Results: CT clearly demonstrated the fracture of the vertebraeand appendix, spinal canal stenosis and retropulsed fragments. MRI showed the injury and tear of ligament and intervertebral disc,abnormal signals and spinal cord compression. Condusion: CT and MR] can make precise diagnosis of burst fractures. CombiningCT with MR] can reveal the injury status of burst fractures and help the surgeon to select a proper surgical technique.     

Severity of vertebral fracture and risk of hip fracture: a nested case�Ccontrol study

Summary  

Severe vertebral fractures strongly predicted subsequent hip fracture in this population-based study. Such high-risk patients should be provided with clinical evaluation and care for osteoporosis.     

A meta-analysis of the efficacy of raloxifene on all clinical and vertebral fractures and its dependency on FRAX®

IntroductionMultiple Outcomes of Raloxifene Evaluation (MORE), a placebo controlled phase III study of raloxifene in postmenopausal osteoporosis, showed that both doses tested (60 mg and 120 mg daily) reduced the risk of vertebral fracture. There was no significant effect on non-vertebral fracture.AimsThe aim of the present study was to evaluate the distribution of fracture risk assessed at baseline using the FRAX® tool in MORE and to determine the efficacy of raloxifene as a function of baseline fracture risk. The effects of raloxifene (60 and 120 mg daily combined) with placebo on the risk of all clinical fractures as well as the risk of morphometric vertebral fracture were examined as a function of baseline fracture risk.MethodsBaseline clinical risk factors and BMD were entered in the FRAX® model to compute the 10-year probability of major osteoporotic fractures. The interaction between fracture probability and treatment efficacy was examined by Poisson regression.ResultsThe 10-year probability of major osteoporotic fractures (with BMD) ranged from 0.9% to 77.2%. The incidence of clinical fractures and morphometric vertebral fractures increased with increasing baseline fracture probabilities. Treatment with raloxifene was associated with an 18% decrease in all clinical fractures compared to placebo treatment (hazard ratio HR = 0.82; 95% CI = 0.71–0.95; p = 0.0063) and a 42% decrease in incident morphometric vertebral fractures (HR = 0.58; 95% CI = 0.48–0.69; p < 0.001). Efficacy was shown over the whole range of fracture probability and the interaction between fracture probability and treatment was not significant. The efficacy or raloxifene on vertebral fracture risk was significantly greater at lower ages. At the 90th percentile of age (75 years) vertebral fracture risk was reduced by 31% irrespective of FRAX® probabilities. In contrast at younger ages, efficacy was higher and increased further still with decreasing fracture probability.ConclusionWe conclude that raloxifene (60 and 120 mg doses combined) significantly decreased the risk of all clinical fractures and morphometric fractures in women. Overall, there was no significant interaction between efficacy and fracture probability. In the case of morphometric vertebral fractures efficacy decreased significantly with increasing age.     

Mechanism of action of β-glycerophosphate on bone cell mineralization

Summary Experiments were performed to determine whether -glycerophosphate (-GP) promoted mineralization in vitro by modulating bone cell metabolic activity and/or serving as a local source of inorganic phosphate ions (Pi). Using MC3T3-E1, ROS 17/2.8, and chick osteoblast-like cells in the presence of -GP or Pi, we examined mineral formation, lactate generation, alkaline phosphatase (AP) activity, and protein and phospholipid synthesis. Neither -GP nor Pi modulated any of the major biosynthetic activities of the bone cells. Thus, we found no change in the levels of phospholipids, and the total protein concentration remained constant. Measurement of lactate synthesis showed that -GP did not effect the rate of anaerobic glycolysis. Evaluation of medium Pi levels clearly indicated that -GP was hydrolyzed by bone cells; within 24 hours, almost 80% of 10 mM -GP was hydrolyzed. It is likely that this local increase in medium Pi concentration promoted rapid mineral deposition. Chemical, energy dispersive X-ray, and Fourier transform infrared analysis of the mineral formed in the presence of -GP showed that it was nonapatitic; moreover, mineral particles were also seen in the culture medium itself. Experiments performed with a cell-free system indicated that mineral particles formed spontaneously in the presence of AP and -GP and were deposited into a collagen matrix. We conclude that medium supplementation with -GP or Pi should not exceed 2 mM. If this value is exceeded, then there will be nonphysiological mineral deposition in the bone cell culture.     

An evaluation of the Fracture Risk Assessment Tool (FRAX®) as an indicator of treatment efficacy: the effects of bazedoxifene and raloxifene on vertebral, nonvertebral, and all clinical fractures as a function of baseline fracture risk assessed by FRAX®

Summary

The relationship between baseline Fracture Risk Assessment Tool (FRAX®) and treatment efficacy was evaluated using data from a pivotal phase 3 study. Relative risk of vertebral, nonvertebral, and all clinical fractures decreased with increasing probability of fracture for bazedoxifene (BZA) versus placebo but remained generally constant for raloxifene (RLX).

Introduction

To determine whether the FRAX® predicts osteoporosis treatment efficacy, we evaluated reductions in fracture incidence associated with BZA and RLX according to baseline fracture risk determined by FRAX® using data from a phase 3 osteoporosis treatment study.

Methods

Hazard ratios (HRs) for effects of BZA and RLX versus placebo on incidence of vertebral, nonvertebral, and all clinical fractures were calculated using a Cox regression model. Cox regression analyses were performed in subgroups at or above 10-year fracture probability thresholds determined by FRAX®.

Results

HRs for the risk of vertebral, nonvertebral, and all clinical fractures versus placebo decreased with increasing 10-year fracture probability for BZA, while those for RLX remained stable. In all 10-year fracture probability subgroups, all BZA doses significantly reduced vertebral fracture risk versus placebo (HR?=?0.22–0.66). BZA at 20, 40, and 20/40 mg significantly reduced risk of nonvertebral fractures (HR?=?0.45, 0.44, and 0.45, respectively) and all clinical fractures (HR?=?0.38, 0.41, and 0.40, respectively) for ≥20.0 % fracture probability. Vertebral fracture risk reductions for RLX 60 mg versus placebo were significant in subgroups at lower fracture probabilities (≥2.5–?≥?10.0 %), but not higher (≥12.5 %), and in no subgroups for nonvertebral or all clinical fractures.

Conclusion

The antifracture efficacy of BZA increased with increasing baseline FRAX® score, but there was no clear relationship between RLX and baseline FRAX®. These findings provide independent confirmation of current literature, suggesting that the relationship between FRAX® and treatment efficacy varies for different agents.     

Comparison of therapeutic effect between percutaneous kyphoplasty and pedicle screw system on vertebral compression fracture

Objective: To compare the clinical efficacy of percutaneous kyphoplasty ( PKP) with pedicle screw system (PS) in the treatment of vertebral compression fracture (VCF). Methods: Eighty-six patients with VCF were treated either by PKP (Group A, n = 30)) or PS ( Group B, n = 56). The anterior, intermediate, and posterior heights of the vertebrae body , visual analogue pain scale( VAS) before and after operation, the duration of operation, and amount of blood loss between two groups were compared. Results: No statistical difference was noted regarding the vertebral height between two groups. Significant difference was seen in VAS, duration of operation and amount of blood loss between the two groups (P<0.0l ). Conclusions: Percutaneous kyphoplasty has the similar therapeutic efficacy with pedicle screw system in treatment of VCF with a minimal invasion, less operation time and blood loss. For those with posterior wall destruction, PS is deemed favorable.     

Androgens and male aging：current evidence of safety and efficacy

Many signs of aging,such as sexual dysfunction,visceral obesity,impaired bone and muscle strength,bear a close resemblance to features of hypogonadism in younger men. The statistical decline of serum testosterone in aging men is solidly documented. It has been presumed that the above features of aging are related to the concurrent decline of androgens,and that correction of the lower-than-normal circulating levels of testosterone will lead to improvement of symptoms of aging. But in essence,the pivotal question whether the age-related decline of testosterone must be viewed as hypogonadism,in the best case reversed by testosterone treatment,has not been definitively resolved. Studies in elderly men with lower-than-normal testosterone report improvement of features of the metabolic syndrome,bone mineral density,of mood and of sexual functioning. But as yet there is no definitive proof of the beneficial effects of restoring testosterone levels to normal in elderly men on clinical parameters. Few of these studies meet as yet rigorous standards of scientific enquiry：double-blind,placebo-controlled design of the study. The above applies also to the assessment of safety of testosterone administration to elderly men. There is so far no convincing evidence that testosterone is a main factor in the development of prostate cancer in elderly men and guidelines for monitoring the development of prostate disease have been developed. It is of note that there are presently no long-term safety data with regard to the prostate. Polycythemia is another potential complication of testosterone treatment. It is dose dependent and can be managed with dose adjustment.     

The efficacy and safety of pain management before and after implementation of hospital-wide pain management standards: is patient safety compromised by treatment based solely on numerical pain ratings?

Inadequate analgesia in hospitalized patients prompted the Joint Commission on Accreditation of Healthcare Organizations in 2001 to introduce standards that require pain assessment and treatment. In response, many institutions implemented treatment guided by patient reports of pain intensity indexed with a numerical scale. Patient safety associated with treatment of pain guided by a numerical pain treatment algorithm (NPTA) has not been examined. We reviewed patient satisfaction with pain control and opioid-related adverse drug reactions before and after implementation of our NPTA. Patient satisfaction with pain management, measured on a 1-5 scale, significantly improved from 4.13 to 4.38 (P < 0.001) after implementation of an NPTA. The incidence of opioid over sedation adverse drug reactions per 100,000 inpatient hospital days increased from 11.0 pre-NPTA to 24.5 post-NPTA (P < 0.001). Of these patients, 94% had a documented decrease in their level of consciousness preceding the event. Although there was an improvement in patient satisfaction, we experienced a more than two-fold increase in the incidence of opioid over sedation adverse drug reactions in our hospital after the implementation of NPTA. Most adverse drug reactions were preceded by a documented decrease in the patient's level of consciousness, which emphasizes the importance of clinical assessment in managing pain. IMPLICATIONS: Although patient satisfaction with pain management has significantly improved since the adoption of pain management standards, adverse drug reactions have more than doubled. For the treatment of pain to be safe and effective, we must consider more than just a one-dimensional numerical assessment of pain.     

Does gender or age affect the efficacy and safety of tolterodine?

PURPOSE: We compared the importance of patient age and gender relative to the intensity of baseline symptoms of overactive bladder in the therapeutic response to the muscarinic receptor antagonist tolterodine. MATERIALS AND METHODS: Data from an open label, observational study of 2,250 patients with overactive bladder treated for 12 weeks with tolterodine were analyzed for alterations in frequency, urgency and urge incontinence, and for global efficacy and tolerability using logistic regression analysis, stratifying for gender, age, baseline symptom intensity and tolterodine dose. RESULTS: Gender or tolterodine dose were not consistently associated with altered treatment efficacy. Greater age was associated with a slight but statistically significant decrease in treatment efficacy. Patients with great baseline symptom intensity had greater treatment associated improvement but a lesser chance to become symptom-free. Even with a large number of patients no statistically significant gender or age associated alterations in the tolerability of tolterodine treatment were detected. CONCLUSIONS: The extent of the therapeutic response to tolterodine is largely determined by the extent of baseline symptoms. While gender does not affect the efficacy or tolerability of tolterodine in a clinically relevant manner, advanced age is associated with a slight decrease in efficacy but not in tolerability.