Correction to: Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?

The article Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?, written by K. L. Ong, D. P. Beall, M. Frohbergh, E. Lau, and J. A. Hirsch was originally published electronically on the publisher's internet portal.

Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?

The 5-year period following 2009 saw a steep reduction in vertebral augmentation volume and was associated with elevated mortality risk in vertebral compression fracture (VCF) patients. The risk of mortality following a VCF diagnosis was 85.1% at 10 years and was found to be lower for balloon kyphoplasty (BKP) and vertebroplasty (VP) patients. INTRODUCTION: BKP and VP are associated with lower mortality risks than non-surgical management (NSM) of VCF. VP versus sham trials published in 2009 sparked controversy over its effectiveness, leading to diminished referral volumes. We hypothesized that lower BKP/VP utilization would lead to a greater mortality risk for VCF patients. METHODS: BKP/VP utilization was evaluated for VCF patients in the 100% US Medicare data set (2005-2014). Survival and morbidity were analyzed by the Kaplan-Meier method and compared between NSM, BKP, and VP using Cox regression with adjustment by propensity score and various factors. RESULTS: The cohort included 261,756 BKP (12.6%) and 117,232 VP (5.6%) patients, comprising 20% of the VCF patient population in 2005, peaking at 24% in 2007-2008, and declining to 14% in 2014. The propensity-adjusted mortality risk for VCF patients was 4% (95% CI, 3-4%; p < 0.001) greater in 2010-2014 versus 2005-2009. The 10-year risk of mortality for the overall cohort was 85.1%. BKP and VP cohorts had a 19% (95% CI, 19-19%; p < 0.001) and 7% (95% CI, 7-8%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the NSM cohort, respectively. The BKP cohort had a 13% (95% CI, 12-13%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the VP cohort. CONCLUSIONS: Changes in treatment patterns following the 2009 VP publications led to fewer augmentation procedures. In turn, the 5-year period following 2009 was associated with elevated mortality risk in VCF patients. This provides insight into the implications of treatment pattern changes and associated mortality risks.

Acid ceramidase treatment enhances the outcome of autologous chondrocyte implantation in a rat osteochondral defect model.

OBJECTIVE: The overall aim of this study was to evaluate how supplementation of chondrocyte media with recombinant acid ceramidase (rhAC) influenced cartilage repair in a rat osteochondral defect model. METHODS: Primary chondrocytes were grown as monolayers in polystyrene culture dishes with and without rhAC (added once at the time of cell plating) for 7 days, and then seeded onto Bio-Gide® collagen scaffolds and grown for an additional 3 days. The scaffolds were then introduced into osteochondral defects created in Sprague-Dawley rat trochlea by a microdrilling procedure. Analysis was performed 6 weeks post-surgery macroscopically, by micro-CT, histologically, and by immunohistochemistry. RESULTS: Treatment with rhAC led to increased cell numbers and glycosaminoglycan (GAG) production (∼2 and 3-fold, respectively) following 7 days of expansion in vitro. Gene expression of collagen 2, aggrecan and Sox-9 also was significantly elevated. After seeding onto Bio-Gide®, more rhAC treated cells were evident within 4 h. At 6 weeks post-surgery, defects containing rhAC-treated cells exhibited more soft tissue formation at the articular surface, as evidenced by microCT, as well as histological evidence of enhanced cartilage repair. Notably, collagen 2 immunostaining revealed greater surface expression in animals receiving rhAC treated cells as well. Collagen 10 staining was not enhanced. CONCLUSION: The results further demonstrate the positive effects of rhAC treatment on chondrocyte growth and phenotype in vitro, and reveal for the first time the in vivo effects of the treated cells on cartilage repair.

Number Needed to Treat with Vertebral Augmentation to Save a Life.

BACKGROUND AND PURPOSE: Evidence from randomized controlled trials for the efficacy of vertebral augmentation in vertebral compression fractures has been mixed. However, claims-based analyses from national registries or insurance datasets have demonstrated a significant mortality benefit for patients with vertebral compression fractures who receive vertebral augmentation. The purpose of this study was to calculate the number needed to treat to save 1 life at 1 year and up to 5 years after vertebral augmentation. MATERIALS AND METHODS: A 10-year sample of the 100% US Medicare data base was used to identify patients with vertebral compression fractures treated with nonsurgical management, balloon kyphoplasty, and vertebroplasty. The number needed to treat was calculated between augmentation and nonsurgical management groups from years 1-5 following a vertebral compression fracture diagnosis, using survival probabilities for each management approach. RESULTS: The adjusted number needed to treat to save 1 life for nonsurgical management versus kyphoplasty ranged from 14.8 at year 1 to 11.9 at year 5. The adjusted number needed to treat for nonsurgical management versus vertebroplasty ranged from 22.8 at year 1 to 23.8 at year 5. CONCLUSIONS: Both augmentation modalities conferred a prominent mortality benefit over nonsurgical management in this analysis of the US Medicare registry, with a low number needed to treat. The calculations based on this data base resulted in a low number needed to treat to save 1 life at 1 year and at 5 years.