The spine journal : official journal of the North American Spine Society
-
Recently, there has been increased public awareness of regulatory actions by the United States Food and Drug Administration (FDA) on spinal devices. There has also been increased scrutiny of the pivotal clinical trials of these devices. ⋯ There has been no decrease in the number of new FDA-approved class III spinal devices since the turn of the century. The majority of devices have been for cervical arthroplasty. By contrast, biologic devices were most likely to go to panel and least likely to be approved after panel. The pivotal trials for nearly all devices were randomized, two-arm, noninferiority trials.
-
Observational Study
Risk-benefit analysis of navigation techniques for vertebral transpedicular instrumentation: a prospective study.
Pedicle screws in spinal surgery have allowed greater biomechanical stability and higher fusion rates. However, malposition is very common and may cause neurologic, vascular, and visceral injuries and compromise mechanical stability. ⋯ Malposition rate, both symptomatic and asymptomatic, in spinal surgery is reduced when using CT-guided placement of transpedicular instrumentation compared with placement under fluoroscopic guidance, with radiation values within the safety limits for health. Larger studies are needed to determine risk-benefit in these patients.
-
Inconsistent associations between modifiable risk factors and chronic back pain (CBP) may be due to the inability of traditional epidemiologic study designs to properly account for an array of potential genetic and environmental confounding factors. The co-twin control research design, comparing modifiable risk factors in twins discordant for CBP, offers a unique way to remove numerous confounding factors. ⋯ Many associations between modifiable lifestyle risk factors and CBP are due to confounding by familial and genetic factors. Severe obesity, depression, and PTSD should be considered in the development of intervention strategies to reduce the prevalence of CBP.
-
Over the past decade, the number of adult spinal deformity (ASD) surgeries has more than doubled in the United States. The complex surgeries needed to manage ASD are associated with significant resource utilization and high cost, making them a primary target for increased scrutiny. Accordingly, it is important to not only demonstrate value in ASD surgery as clinical effectiveness but also to translate outcome assessment to cost-effectiveness. ⋯ There is a significant difference in direct hospital costs versus Medicare allowable rates in ASD surgery and in turn, there is a similar difference in the cost per QALY calculation. Utilizing Medicare allowable rates not only underestimates (17%) the cost of ASD surgery, but it also creates inaccurate and unrealistic expectations for researchers and policymakers.
-
Randomized Controlled Trial
Effectiveness of physiotherapy for seniors with recurrent headaches associated with neck pain and dysfunction: a randomized controlled trial.
A previous study demonstrated that in seniors, the presence of cervical musculoskeletal impairment was not specific to cervicogenic headache but was present in various recurrent headache types. Physiotherapy treatment is indicated in those seniors diagnosed with cervicogenic headache but could also be adjunct treatment for those with cervical musculoskeletal signs who are suspected of having transitional headaches. ⋯ Physiotherapy treatment provided benefits over usual care for seniors with recurrent headache associated with neck pain and dysfunction.