NCT02896114 - 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)

Mathieu L, Vialle R, Thevenin-Lemoine C, Mary P, Damsin JP
Association of Ilizarov's technique and intramedullary rodding in the treatment of congenital pseudarthrosis of the tibia. J Child Orthop. 2008 Dec;2(6):449-55. doi: 10.1007/s11832-008-0139-4. Epub 2008 Oct 28.
Ohnishi I, Sato W, Matsuyama J, Yajima H, Haga N, Kamegaya M, Minami A, Sato M, Yoshino S, Oki T, Nakamura K
Treatment of congenital pseudarthrosis of the tibia: a multicenter study in Japan. J Pediatr Orthop. 2005 Mar-Apr;25(2):219-24.
Romanus B, Bollini G, Dungl P, Fixsen J, Grill F, Hefti F, Ippolito E, Tudisco C, Wientroub S
Free vascular fibular transfer in congenital pseudoarthrosis of the tibia: results of the EPOS multicenter study. European Paediatric Orthopaedic Society (EPOS). J Pediatr Orthop B. 2000 Apr;9(2):90-3.

A Retrospective Study of Surgical Treatment of Congenital Pseudarthrosis of Tibia in China: a Muti-centre Study

Clinical trial NCT02896114 - References