Bone Fracture — HealthEast Community Hip and Knee Replacement Registry
Citation(s)
Gioe TJ, Killeen KK, Grimm K, Mehle S, Scheltema K Why are total knee replacements revised?: analysis of early revision in a community knee implant registry. Clin Orthop Relat Res. 2004 Nov;(428):100-6.
Gioe TJ, Killeen KK, Mehle S, Grimm K Implementation and application of a community total joint registry: a twelve-year history. J Bone Joint Surg Am. 2006 Jun;88(6):1399-404.
Gioe TJ, Sharma A, Tatman P, Mehle S Do "premium" joint implants add value?: analysis of high cost joint implants in a community registry. Clin Orthop Relat Res. 2011 Jan;469(1):48-54. doi: 10.1007/s11999-010-1436-z.
Johnson TC, Tatman PJ, Mehle S, Gioe TJ Revision surgery for patellofemoral problems: should we always resurface? Clin Orthop Relat Res. 2012 Jan;470(1):211-9. doi: 10.1007/s11999-011-2036-2.
HealthEast Community Hip and Knee Replacement Registry
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.
