Osteoporosis — Pedicle Screw Fixation in Osteoporotic Lumbar Spine
Citation(s)
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Okuyama K, Abe E, Suzuki T, Tamura Y, Chiba M, Sato K Influence of bone mineral density on pedicle screw fixation: a study of pedicle screw fixation augmenting posterior lumbar interbody fusion in elderly patients. Spine J. 2001 Nov-Dec;1(6):402-7.
Pannell WC, Savin DD, Scott TP, Wang JC, Daubs MD Trends in the surgical treatment of lumbar spine disease in the United States. Spine J. 2015 Aug 1;15(8):1719-27. doi: 10.1016/j.spinee.2013.10.014. Epub 2013 Oct 31.
Tokuhashi Y, Matsuzaki H, Oda H, Uei H Clinical course and significance of the clear zone around the pedicle screws in the lumbar degenerative disease. Spine (Phila Pa 1976). 2008 Apr 15;33(8):903-8. doi: 10.1097/BRS.0b013e31816b1eff.
Zou D, Jiang S, Zhou S, Sun Z, Zhong W, Du G, Li W Prevalence of Osteoporosis in Patients Undergoing Lumbar Fusion for Lumbar Degenerative Diseases: A Combination of DXA and Hounsfield Units. Spine (Phila Pa 1976). 2020 Apr 1;45(7):E406-E410. doi: 10.1097/BRS.0000000000003284.
Zou D, Li W, Deng C, Du G, Xu N The use of CT Hounsfield unit values to identify the undiagnosed spinal osteoporosis in patients with lumbar degenerative diseases. Eur Spine J. 2019 Aug;28(8):1758-1766. doi: 10.1007/s00586-018-5776-9. Epub 2018 Oct 10.
Zou D, Muheremu A, Sun Z, Zhong W, Jiang S, Li W Computed tomography Hounsfield unit-based prediction of pedicle screw loosening after surgery for degenerative lumbar spine disease. J Neurosurg Spine. 2020 Jan 3:1-6. doi: 10.3171/2019.11.SPINE19868. [Epub ahead of print]
Pedicle Screw Fixation in Osteoporotic Patients With Degenerative Lumbar Diseases: a Prospective Cohort Study
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
