Fracture — Pre-drilling or Self Drilling External Fixation Pins
Citation(s)
Abouzgia MB, Symington JM Effect of drill speed on bone temperature. Int J Oral Maxillofac Surg. 1996 Oct;25(5):394-9.
Antoci V, Ono CM, Antoci V Jr, Raney EM Pin-tract infection during limb lengthening using external fixation. Am J Orthop (Belle Mead NJ). 2008 Sep;37(9):E150-4.
Bachus KN, Rondina MT, Hutchinson DT The effects of drilling force on cortical temperatures and their duration: an in vitro study. Med Eng Phys. 2000 Dec;22(10):685-91.
Bonfield W, Li CH The temperature dependence of the deformation of bone. J Biomech. 1968 Dec;1(4):323-9.
Moroni A, Faldini C, Marchetti S, Manca M, Consoli V, Giannini S Improvement of the bone-pin interface strength in osteoporotic bone with use of hydroxyapatite-coated tapered external-fixation pins. A prospective, randomized clinical study of wrist fractures. J Bone Joint Surg Am. 2001 May;83-A(5):717-21.
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.