Lower Limb Amputation — Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
Citation(s)
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Epstein RA, Heinemann AW, McFarland LV Quality of life for veterans and servicemembers with major traumatic limb loss from Vietnam and OIF/OEF conflicts. J Rehabil Res Dev. 2010;47(4):373-85. doi: 10.1682/jrrd.2009.03.0023.
Fernie GR, Holliday PJ Volume fluctuations in the residual limbs of lower limb amputees. Arch Phys Med Rehabil. 1982 Apr;63(4):162-5.
Krueger CA, Wenke JC, Ficke JR Ten years at war: comprehensive analysis of amputation trends. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S438-44. doi: 10.1097/TA.0b013e318275469c.
Sanders JE, Fatone S Residual limb volume change: systematic review of measurement and management. J Rehabil Res Dev. 2011;48(8):949-86. doi: 10.1682/jrrd.2010.09.0189.
Schultz AE, Baade SP, Kuiken TA Expert opinions on success factors for upper-limb prostheses. J Rehabil Res Dev. 2007;44(4):483-9. doi: 10.1682/jrrd.2006.08.0087.
Zachariah SG, Saxena R, Fergason JR, Sanders JE Shape and volume change in the transtibial residuum over the short term: preliminary investigation of six subjects. J Rehabil Res Dev. 2004 Sep;41(5):683-94. doi: 10.1682/jrrd.2003.10.0153.
Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
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.