Osteoarthritis, Knee — All-Polyethylene Tibias in TKA: PS vs CS Implants
Citation(s)
Adalberth G, Nilsson KG, Byström S, Kolstad K, Milbrink J Low-conforming all-polyethylene tibial component not inferior to metal-backed component in cemented total knee arthroplasty: prospective, randomized radiostereometric analysis study of the AGC total knee prosthesis. J Arthroplasty. 2000 Sep;15(6):783-92.
Gioe TJ, Maheshwari AV The all-polyethylene tibial component in primary total knee arthroplasty. J Bone Joint Surg Am. 2010 Feb;92(2):478-87. doi: 10.2106/JBJS.I.00842. Review.
Yassin M, Garti A, Weissbrot M, Ashkenazi U, Khatib M, Robinson D All-polyethylene tibial components are not inferior to metal-backed tibial components in long-term follow-up of knee arthroplasties. Eur J Orthop Surg Traumatol. 2015 Aug;25(6):1087-91. doi: 10.1007/s00590-015-1645-y. Epub 2015 May 26.
All-Polyethylene Tibial Components in Total Knee Arthroplasty: A Radiostereometric Analysis Comparing Posterior Stabilizing and Condylar Stabilizing Implants
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.
