Ahl T, Dalén N, Lundberg A, Bylund C Early mobilization of operated on ankle fractures. Prospective, controlled study of 40 bimalleolar cases. Acta Orthop Scand. 1993 Feb;64(1):95-9.
Cimino W, Ichtertz D, Slabaugh P Early mobilization of ankle fractures after open reduction and internal fixation. Clin Orthop Relat Res. 1991 Jun;(267):152-6.
Court-Brown CM, Caesar B Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. Epub 2006 Jun 30. Review.
Egol KA, Dolan R, Koval KJ Functional outcome of surgery for fractures of the ankle. A prospective, randomised comparison of management in a cast or a functional brace. J Bone Joint Surg Br. 2000 Mar;82(2):246-9.
Gul A, Batra S, Mehmood S, Gillham N Immediate unprotected weight-bearing of operatively treated ankle fractures. Acta Orthop Belg. 2007 Jun;73(3):360-5.
Hedström M, Ahl T, Dalén N Early postoperative ankle exercise. A study of postoperative lateral malleolar fractures. Clin Orthop Relat Res. 1994 Mar;(300):193-6.
Michelson JD, Magid D, McHale K Clinical utility of a stability-based ankle fracture classification system. J Orthop Trauma. 2007 May;21(5):307-15.
O'Sullivan ME, Bronk JT, Chao EY, Kelly PJ Experimental study of the effect of weight bearing on fracture healing in the canine tibia. Clin Orthop Relat Res. 1994 May;(302):273-83.
van Laarhoven CJ, Meeuwis JD, van der WerkenC Postoperative treatment of internally fixed ankle fractures: a prospective randomised study. J Bone Joint Surg Br. 1996 May;78(3):395-9.
Immediate Unprotected Weight-Bearing and Range of Motion After Open Reduction and Internal Fixation of Unstable Ankle Fractures. A Historical Control Group Comparative 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.
