NCT05141227 - 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)

Mauffrey C, Vasario G, Battiston B, Lewis C, Beazley J, Seligson D
Tibial pilon fractures: a review of incidence, diagnosis, treatment, and complications. Acta Orthop Belg. 2011 Aug;77(4):432-40.
Michelson J, Moskovitz P, Labropoulos P
The nomenclature for intra-articular vertical impact fractures of the tibial plafond: pilon versus pylon. Foot Ankle Int. 2004 Mar;25(3):149-50. doi: 10.1177/107110070402500307.
Ruedi TP, Allgower M
The operative treatment of intra-articular fractures of the lower end of the tibia. Clin Orthop Relat Res. 1979 Jan-Feb;(138):105-10.

Two-stage Open Reduction and Internal Fixation Versus Single-stage External Fixation for Complex Intra-articular Distal Tibial Fractures : A Randomized Controlled Trial

Details for clinical trial NCT05141227

Clinical trial NCT05141227 - References