Vertebral Augmentation: Is It Time to Get Past the Pain? A Consensus Statement from the Sardinia Spine and Stroke Congress.

Vertebral augmentation has been used to treat painful vertebral compression fractures and metastatic lesions in millions of patients around the world. An international group of subject matter experts have considered the evidence, including but not limited to mortality. These considerations led them to ask whether it is appropriate to allow the subjective measure of pain to so dominate the clinical decision of whether to proceed with augmentation. The discussions that ensued are related below.

Midterm Clinical and Radiologic Outcomes after Percutaneous Interspinous Spacer Treatment for Neurogenic Intermittent Claudication.

PURPOSE: To evaluate the midterm clinical and radiologic outcome of percutaneous interspinous process spacer (IPS) treatment for neurogenic intermittent claudication (NIC) in patients who fail conservative treatment. METHODS: Consecutive patients with NIC, lumbar spinal stenosis confirmed on magnetic resonance imaging, failure of conservative management for at least 6 months, and treatment with percutaneous IPS were included. Visual analog scale (VAS) and Oswestry Disability Index (ODI) scores were recorded at baseline, 1 month, 1 year and 3 years after treatment. Spinal canal and foraminal cross-sectional areas were calculated from multidetector computed tomography at baseline and 1 year. RESULTS: There were 80 patients treated with 94 IPS devices; 83% of patients received a single IPS; 78% of IPS devices were placed at L4-L5. An IPS dislocation was the single periprocedural major complication. VAS score of 8.1 ± 2 before treatment was reduced to 4.4 ± 2 at 1 month after treatment (P = .0001); ODI score of 23.3 ± 10 before treatment was reduced to 11.7 ± 8.5 at 1 month after treatment (P = .0001). These significant reductions were durable at 1-year and 3-year follow-up evaluations (P < .01). Spinal canal and foraminal cross-sectional area increased by 15% at 1 year (P = .0001). CONCLUSIONS: Patients with NIC who failed conservative treatment and were treated with percutaneous IPS achieved significant gains in pain relief and reduced disability that remained durable at 3-year clinical follow-up evaluation. This outcome was accompanied by significant increases in spinal canal and foraminal cross-sectional areas at the treated level.

Treatment of painful Modic type I changes by vertebral augmentation with bioactive resorbable bone cement.

INTRODUCTION: Low back pain is one of the most common causes of seeking medical attention in industrialized western countries. End plate degenerative changes in the acute phase, formally referred to as Modic type I, represent a specific cause. The aim of this study is to evaluate the effectiveness of vertebral augmentation with calcium sulfate and hydroxyapatite resorbable cement in patients with low back pain resistant to conservative treatment whose origin can be recognized in Modic type I changes. METHODS: From February 2009 to October 2013, 1,124 patients with low back pain without radicular symptoms underwent physical and imaging evaluation. Stringent inclusion criteria elected 218 to vertebral augmentation with resorbable cement. Follow-up period was 1 year. RESULTS: One hundred seventy-two (79 %) patients improved quickly during the first 4 weeks after treatment. Forty-two (19 %) patients showed a more gradual improvement over the first 6 months, and at 1 year, their pain level did not differ from that of the previous group. In both groups, pain did not resolved completely, but patients showed significant improvement in their daily life activities. Two (1 %) patients did not show any improvement. Two (1 %) patients died for other reasons. There were no complications related to the procedures. CONCLUSION: Vertebroplasty with bioactive resorbable bone cement seems to be an effective therapeutic option for patients with low back pain resistant to conservative treatment whose origin could be recognized in Modic type I end plate degenerative changes.

Lutein and zeaxanthin supplementation in preterm very low-birth-weight neonates in neonatal intensive care units: a multicenter randomized controlled trial.

BACKGROUND: Human milk feeding protects against oxidative stress-induced damage in preterm neonates, including severe multifactorial diseases such as retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), and bronchopulmonary dysplasia (BPD). The carotenoids, which are not found in formula milk, might play a key role in these actions. METHODS: A multicenter, double-blind, randomized controlled trial was conducted in three tertiary Italian neonatal intensive care units. All preterm infants < 32(+6) weeks' gestational age were eligible and were randomized to a single, oral, daily 0.5-mL dose of carotenoid supplementation (0.14 mg lutein + 0.0006 mg zeaxanthin) or placebo (5% glucose solution) from birth till 36 weeks' corrected gestational age. Primary outcomes were threshold ROP, NEC > second stage, and BPD. Surveillance for detection of these diseases and for intolerance/adverse effects was performed. RESULTS: No treatment-related adverse effect was documented in the 229 analyzed infants, whose clinical/demographical characteristics were similar in the two groups. Threshold ROP incidence did not significantly differ in treated (6.2%) versus not treated infants (10.3%; p = 0.18). The same occurred for NEC (1.7% versus 5.1%; p = 0.15) and BPD (4.5% versus 10.3%; p = 0.07). Noteworthy, the progression rate from early ROP stages to threshold ROP was decreased by 50% (0.30 versus 0.44; p = 0.23). CONCLUSION: Lutein/zeaxanthin supplementation in preterm infants is well tolerated. No significant effect was seen on threshold ROP, NEC, or BPD. The decreasing trends of these outcomes in the treatment group need to be assessed and confirmed on larger sample-sizes.

Effectiveness of a bone substitute (CERAMENT™) as an alternative to PMMA in percutaneous vertebroplasty: 1-year follow-up on clinical outcome.

PURPOSE: The aim of the study was to evaluate the efficacy of an injectable and partly absorbable calcium bone cement (CERAMENT™, Bone Support, Sweden) in the treatment of osteoporotic or traumatic vertebral fractures by percutaneous vertebroplasty. METHODS: From March 2009 to October 2010 an open, prospective study in two centres was performed. 33 patients with symptomatic vertebral fractures were enrolled. Patients were included based on evaluation by X-ray, CT, and MRI. Clinical evaluation by Visual Analogue Scale (VAS, 0-10) and Oswestry Disability index test (ODI, 0-100 %) was performed before the operation as well as 1, 6 and 12 months after the procedure. Radiology assessment post-procedure was carried out by X-ray, CT, and MRI at 1, 6 and 12 months post-op. Intake of analgesic medications pre- and post-procedure was monitored. RESULTS: 66 vertebral bodies underwent percutaneous vertebroplasty. VAS score demonstrated a significant decrease from 8.61 (SD 19.8) pre-operatively to 2.48 (SD 2.36) at 1 month. The score was 2.76 (SD 2.68) at 6 months and 1.36 (SD 1.33) at the latest follow up. ODI score dropped significantly from 58.86 pre-op to 26.94 at 6 months and further down to 7.61 at 12 months. No re-fractures or adjacent level fractures were reported. CONCLUSION: Data show that CERAMENT can be a substitute of PMMA in the treatment of osteoporotic and traumatic vertebral fractures, especially in young patients.

Percutaneous vertebroplasty in osteoporotic patients: an institutional experience of 1,634 patients with long-term follow-up.

PURPOSE: To assess long-term clinical outcome of percutaneous vertebroplasty (PV). MATERIALS AND METHODS: PV was performed in 1,634 patients (1,387 women; median age 73 years ± 9.3) with painful osteoporotic vertebral compression fractures (VCFs). All patients had back pain that persisted for ≥ 2 months with a concordant magnetic resonance imaging study. After PV, medical therapy for osteoporosis was continued, and patients were prospectively evaluated (follow-up 11.8-44.9 months, mean 25.0 months). Visual analog scale (VAS), Oswestry Disability Index (ODI), analgesic drug use, and use of external brace support were recorded at baseline and during follow-up. New occurrences of symptomatic vertebral fractures were recorded. RESULTS: The mean VAS score of 7.94 significantly improved to 1.12 at the primary endpoint (P < .001). Differences in patterns of analgesic usage compared with baseline values were highly statistically significant (marginal homogeneity test, P < .001). Median ODI values of 82% before treatment significantly decreased to 6% (P < .001). Before intervention, 1,279 patients wore a brace; 1,167 (91.2%) patients did not wear a brace after PV (χ(2) = 31.005, P < .0001). A new painful fracture with a significant higher proportion of contiguous vertebrae (63.6%) occurred in 214 (13.1%) patients (z = 7.59, P = .025). CONCLUSIONS: PV can provide durable pain relief and improvement in ambulation in patients with VCFs.

Painful pathologic fracture of the humerus: percutaneous osteoplasty with bone marrow nails under hybrid computed tomography and fluoroscopic guidance.

A case of a 75-year-old patient with a painful pathologic humeral shaft fracture, with unacceptably high surgical risk and unsatisfactory analgesia is reported. In this case, impaired arm function and persistent pain with conservative management resulted in a poor quality of life. Palliation with image-guided percutaneous osteoplasty was considered. Because of potential cement leakage, inadequate fracture reduction, the site of the fracture, and the mobility of the joints in that area, image-guided percutaneous delivery of metallic bone marrow nails implanted together with polymethyl methacrylate (PMMA) osteoplasty was performed. This procedure achieved humeral shaft stabilization, bone fragment alignment, fracture reduction, and pain relief.

Vertebral augmentation: 7 years experience.

Percutaneous vertebroplasty and kyphoplasty are procedures used to treat pain associated with vertebral compression fractures. Controversies are still open regarding indications, efficacy and safety of the procedures, and regarding the potential benefits, advantages and shortcomings of PV versus KP.Aim of this article is to report 7 years' experience in vertebral augmentation of the E.VE.RES.T. (European VErtebroplasty RESearch Team) group. The main topics are the treatments of hemangioma and malignant lesions, technically challenging cases such as vertebra plana, multifragmented fractures, multilevel treatments, refracture of augmented vertebra, and treatment of cervical junction and sacrum.

Osteoplasty: Percutaneous Bone Cement Injection beyond the Spine.

Percutaneous osteoplasty, the injection of bone cement into a painful bone lesion refractory to conventional therapy (radiotherapy, chemotherapy, and narcotic analgesia), is performed to allow for immediate bone structure consolidation, reduce the risk of a pathological fracture, achieve pain regression, and improve mobility. In this article, the technique of this procedure and a review of the current literature including the author's personal large series will be described.

Single Level Percutaneous Vertebroplasty for Vertebral Hemangiomata - A Review of Outcomes.

BACKGROUND: Percutaneous vertebroplasty is a minimally invasive technique to treat patients with symptomatic vertebral hermangiomata. OBJECTIVES: We present a single-operator series of cases to demonstrate the clinical outcomes and complication profiles for this technique. STUDY DESIGN: This is a retrospective multi-center cohort study. SETTING: Procedures were performed across multiple hospitals in Italy by a single proceduralist. METHODS: All patients with symptomatic vertebral hermangiomata that had percutaneous vertebroplasty over a 14-year period (March 1999 to April 2013) by a single proceduralist were included in this study. Information collected included demographic data, vertebral level of intervention, cement volume used, and the Visual Analogue Score for pain that was assessed pre- and post-intervention. Patients were followed up for a minimum of one year. RESULTS: Percutaneous vertebroplasty was performed for 50 patients. All patients had an improvement in pain, with 39 patients (78%) reporting complete pain relief. A unipedicular approach was undertaken in 41 cases (82%), and bipedicular approach in 8 patients (16%), while a transoral approach was used in one patient. The mean cement volume per vertebral level was 6.8 mL (1 - 18 mL). Recurrent symptoms occurred in 2 patients (4%) requiring repeat vertebroplasty. There were no cases of symptomatic cement leak, and no cases of procedural morbidity or mortality. LIMITATIONS: As a multicenter study conducted over a 14-year time period, there may be heterogeneity in procedural technique and rehabilitation protocols. There were no cases of cement leakage in our study, which could be an underreporting of cases. This is could be due to none of our patients receiving a post procedural computerized tomography scan, which is more sensitive in detecting cement leakage when compared to procedural fluoroscopy. CONCLUSION: Percutaneous vertebroplasty is associated with good post-procedural outcomes in patients with vertebral hermangiomata. Complications such as neurological injury and cement leakages are rare.