NCT02050698 - Clinical Trial References

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.

Citation(s)

Clapper MF, O'Brien TJ, Lyons PM
Fractures of the fifth metatarsal. Analysis of a fracture registry. Clin Orthop Relat Res. 1995 Jun;(315):238-41. Review.
Gray AC, Rooney BP, Ingram R
A prospective comparison of two treatment options for tuberosity fractures of the proximal fifth metatarsal. Foot (Edinb). 2008 Sep;18(3):156-8. doi: 10.1016/j.foot.2008.02.002. Epub 2008 May 19.
Heineck J, Wolz M, Haupt C, Rammelt S, Schneiders W
Fifth metatarsal avulsion fracture: a rational basis for postoperative treatment. Arch Orthop Trauma Surg. 2009 Aug;129(8):1089-92. doi: 10.1007/s00402-008-0756-x. Epub 2008 Sep 26.
Shahid MK, Punwar S, Boulind C, Bannister G
Aircast walking boot and below-knee walking cast for avulsion fractures of the base of the fifth metatarsal: a comparative cohort study. Foot Ankle Int. 2013 Jan;34(1):75-9. doi: 10.1177/1071100712460197.
Todd KH, Funk KG, Funk JP, Bonacci R
Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9.
Vorlat P, Achtergael W, Haentjens P
Predictors of outcome of non-displaced fractures of the base of the fifth metatarsal. Int Orthop. 2007 Feb;31(1):5-10. Epub 2006 May 23.
Wiener BD, Linder JF, Giattini JF
Treatment of fractures of the fifth metatarsal: a prospective study. Foot Ankle Int. 1997 May;18(5):267-9.

Hard-soled Shoe Versus Short Leg Walking Cast for a Fifth Metatarsal Avulsion Fracture: A Randomized Multicenter Noninferiority Trial

Clinical trial NCT02050698 - References