NCT03379935 - 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)

Duckworth AD, Wickramasinghe NR, Clement ND, Court-Brown CM, McQueen MM
Radial head replacement for acute complex fractures: what are the rate and risks factors for revision or removal? Clin Orthop Relat Res. 2014 Jul;472(7):2136-43. doi: 10.1007/s11999-014-3516-y.
Heijink A, Kodde IF, Mulder PG, Veltman ES, Kaas L, van den Bekerom MP, Eygendaal D
Radial Head Arthroplasty: A Systematic Review. JBJS Rev. 2016 Oct 18;4(10). pii: 01874474-201610000-00001. doi: 10.2106/JBJS.RVW.15.00095.
Heijink A, Kodde IF, Mulder PGH, Van Dijk CN, Eygendaal D
Cemented bipolar radial head arthroplasty: midterm follow-up results. J Shoulder Elbow Surg. 2016 Nov;25(11):1829-1838. doi: 10.1016/j.jse.2016.05.017. Epub 2016 Aug 9.

Radial Head Arthroplasty: A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty

Clinical trial NCT03379935 - References