Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

This pilot monocenter study in 30 patients with painful osteoporotic vertebral compression fractures compared two vertebral augmentation procedures. Over a 3-year post-surgery follow-up, pain/disability/quality of life remained significantly improved with both balloon kyphoplasty and SpineJack® techniques, but the latter allowed better vertebral body height restoration/kyphosis correction. INTRODUCTION: Patient follow-up rarely exceed 2 years in trials comparing vertebral augmentation procedures for the treatment of painful osteoporotic vertebral compression fractures (VCFs). This pilot, investigator-initiated, prospective study aimed to compare long-term results of SpineJack® (SJ) and balloon kyphoplasty (BKP). Preliminary results showed that SJ resulted in a better restoration of vertebral heights and angles, maintained over 12 months. METHODS: Thirty patients were randomized to SJ (n = 15) or BKP (n = 15). Clinical endpoints were analgesic consumption, back pain intensity (visual analog scale (VAS)), the Oswestry Disability Index (ODI), and quality of life (EQ-VAS score). They were recorded preoperatively, at 5 days (except EQ-VAS), 1, 3, 6, 12, and 36 months post-surgery. Spine X-rays were taken 48 h prior to the procedure and 5 days, 6, 12, and 36 months after. RESULTS: Clinical improvements were observed with both procedures over the 3-year period without significant inter-group differences, but the final mean EQ-5Dindex score was significantly in favor of the SJ group (0.93 ± 0.11 vs 0.81 ± 0.09; p = 0.007). Vertebral height restoration/kyphotic correction was still evident at 36 months with a greater mean correction of anterior (10 ± 13% vs 2 ± 8% for BKP, p = 0.007) and central height (10 ± 11% vs 3 ± 7% for BKP, p = 0.034) and a larger correction of the vertebral body angle (- 5.0° ± 5.1° vs 0.4° ± 3.4°; p = 0.003) for SJ group. CONCLUSIONS: In this study, both techniques displayed very good long-term clinical efficiency and safety in patients with osteoporotic VCFs. Over the 3-year follow-up, vertebral body height restoration/kyphosis correction was better with the SpineJack® procedure.

Correction to: Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

The author list was incomplete. The complete list of authors is the following: D. Noriega, F. Rodrίguez-Monsalve, R. Ramajo, I.Sánchez-Lite, B. Toribio, F. Ardura. The corresponding author regrets sincerely this error. The original article got update.

Safety and clinical performance of kyphoplasty and SpineJack(®) procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

UNLABELLED: Clinical performance and safety of two percutaneous vertebral cement augmentation (VA) procedures (SpineJack® and Kyphx Xpander® balloon) were compared in patients with osteoporotic compression fractures. Both techniques were safe, efficient, and led to a rapid and marked improvement in clinical signs; nevertheless, SpineJack showed better restoration of vertebral heights and angles, maintained over time. INTRODUCTION: In patients with osteoporotic vertebral compression fractures (VCFs), both SpineJack® (SJ) and balloon kyphoplasty (BKP) led to a rapid and marked improvement in clinical signs. This pilot, monocentric, investigator-initiated, prospective study aimed to compare two percutaneous vertebral augmentation procedures in the painful osteoporotic VCF treatment. METHODS: Thirty patients were randomized to receive SJ (n = 15) or BKP (n = 15). Analgesic consumption, back pain intensity (visual analog scale (VAS)), and Oswestry Disability Index (ODI) scores were recorded preoperatively, at 5 days and 1, 3, 6, and 12 months post-surgery. Quality of life (EQ-VAS score) was evaluated at 1, 3, 6, and 12 months. Spine X-rays were taken 48 h prior to procedure and 5 days and 6 and 12 months after. RESULTS: SpineJack® led to a significantly shorter intervention period (23 vs 32 min; p < 0.001), a strong, rapid, and long-lasting decline in pain (94 vs 82 % at 12 months) and in functional disability (94 vs 90 % at 12 months), a greater and sustainable mean correction of anterior (12 ± 13 vs 0 ± 7 % for BKP, p = 0.003) and central height (12 ± 10 vs 2 ± 6 % for BKP, p = 0.001) at 12 months, and a larger restoration of the vertebral body angle still evident 12 months after implantation (-4.4° ± 5.8° vs 0.2° ± 3.0° for BKP; p = 0.012). CONCLUSIONS: This pilot study showed that both techniques were safe and efficient for the osteoporotic VCF treatment. Radiological results indicate that the SpineJack® procedure has a higher potential for vertebral body height restoration and maintenance over time.

Prevalence of nonalcoholic fatty liver disease in a Spanish town: a population-based study.

OBJECTIVE: Nonalcoholic fatty liver disease (NAFLD) is western countries' most important cause of hepatic steatosis and hypertransaminasemia. The objective was to evaluate the prevalence of NAFLD among 261,025 people in the East Valladolid public healthcare area in Spain. METHODS: We randomly selected 1800 participants from a public healthcare system card database, representing most of the population. We performed a medical record, measurement of anthropometric parameters, abdominal ultrasound, and blood tests to rule out hepatic disease in all patients. We calculated the FLI score in all patients. RESULTS: 448 participants agreed to participate in the study. The prevalence of nonalcoholic fatty liver disease in our study was 22.3% [18.5%-26.2%]. Prevalence was highest between 50 and 70 years, increasing with age (p < 0.006). There were no significant differences in sex (p = 0.338). The median Body mass index was 27.2, and NAFLD was related to the weight (p < 0,001) and abdominal perimeter (p < 0.001). Logistic regression analysis showed GGT lower than 26 UI/ml, body mass index higher than 31, and HOMA IR greater than 2.54 as independent factors to predict NAFLD in the sample. NAFLD diagnosis matched with an elevated FLI score in 88% of cases. CONCLUSION: According to other epidemiological studies, NAFLD's prevalence is very high. A complete study with a clinical consultation, image studies, and blood tests in all patients allows us to assess the prevalence of NAFLD in the population.