Search

Medical and surgical research has always had a long-standing relationship with industry-based funding from sources, such as drug and device companies. Concerns exist surrounding the association between funding sources, outcome from studies and publication bias. Studies demonstrating increased odds ratios associated with positive results in industry sponsored studies across medicine have stimulated Cochrane reviews, literature reviews and other articles to examine this relationship further. In spine surgery in particular, studies with positive results have an odds ratio of 3.3 of being published. This article discusses the biases associated with industry sponsorship, possible ways to reduce such biases and ways to improve transparency in research relationships. This article explores the types of bias that can be encountered at different stages of research including previous trials in spine surgery. The means of improving transparency including the Physician Payment Sunshine Act of 2010 and International Committee of Medical Journal Editors (ICJME) accreditation are discussed. We recognize that physicians undertaking industry sponsored research should be protected and not be liable to perverse incentives. We conclude that mitigating bias in industry sponsored research is a multistep process and needs a multifaceted approach. The main beneficiary of research should be patients and as such a collective effort from medical professionals, health care institutions, journals and industry should approach research, and publications with that in mind.

Study Design Systematic review and meta-analysis.Objective Surgical management of osteoporotic vertebral compression fractures (OVCFs) has traditionally consisted of vertebroplasty or kyphoplasty procedures. Mechanical percutaneous vertebral body augmentation (MPVA) systems have recently been introduced as alternatives to traditional methods. However, the effectiveness of MPVA systems vs conventional augmentation techniques for OVCFs remains unclear. This serves as the premise for this study.Methods A systematic review and meta-analysis was conducted as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)guidelines. Studies of interest included randomized controlled trials (RCTs) which directly compared patient outcomes following kyphoplasty to patients treated with MPVA systems. Clinical and radiological findings were collated and compared for significance between cohorts.Results 6 RCTs were identified with 1024 patients total. The mean age of all patients was 73.5 years. 17% of the cohort were male, 83% were female. 515 patients underwent kyphoplasty and 509 underwent mechanical vertebral body augmentation using MPVA systems. MPVAs showed similar efficacy for restoration of vertebral body height (P= .18), total complications (P= .36), cement extravasation (P= .58) and device-related complications (P= .06). MPVAs also showed reduced rates of all new fractures (16.4% vs 22.2%; P= .17) and adjacent fractures (14.7% vs 18.9%; P= .23), with improved visual analogue scale (VAS) scores at 6-month (P= .13).Conclusion The results of this meta-analysis highlight no significant improvement in clinical or radiological outcomes for MPVA systems when compared to balloon kyphoplasty for vertebral body augmentation. Further research is needed to establish a true benefit over traditional operative methods.