NCT03312998 - 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)

Moon MS, Choi WT, Sun DH, Chae JW, Ryu JS, Chang H, Lin JF
Instrumented ligamentotaxis and stabilization of compression and burst fractures of dorsolumbar and mid-lumbar spines. Indian J Orthop. 2007 Oct;41(4):346-53. doi: 10.4103/0019-5413.36999.
Moon MS, Kim SS, Lee BJ, Moon JL, Lin JF, Moon YW
Radiographic assessment of congenital C2-3 synostosis. J Orthop Surg (Hong Kong). 2010 Aug;18(2):143-7.
Riaz-ur-Rehman, Azmatullah, Azam F, Mushtaq, Shah M
Treatment of traumatic unstable thoracolumbar junction fractures with transpedicular screw fixation. J Pak Med Assoc. 2011 Oct;61(10):1005-8.
Wang L, Yan J, Li Y, Xu K, Li S, Tang P, Li H
The influence of hydroxypropyl-ß-cyclodextrin on the solubility, dissolution, cytotoxicity, and binding of riluzole with human serum albumin. J Pharm Biomed Anal. 2016 Jan 5;117:453-63. doi: 10.1016/j.jpba.2015.09.033. Epub 2015 Oct 9.

Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorso Lumbar Spine Fracture

Clinical trial NCT03312998 - References