NCT06147219 - 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)

Fracture and dislocation compendium
Orthopaedic Trauma Association Committee for Coding and Classification. J Orthop Trauma. 1996;10 Suppl 1:v-ix, 1-154. No abstract available.
Omerovic D, Lazovic F, Hadzimehmedagic A
Static or dynamic intramedullary nailing of femur and tibia. Med Arch. 2015 Apr;69(2):110-3. doi: 10.5455/medarh.2015.69.110-113. Epub 2015 Apr 6.
Vaughn J, Gotha H, Cohen E, Fantry AJ, Feller RJ, Van Meter J, Hayda R, Born CT
Nail Dynamization for Delayed Union and Nonunion in Femur and Tibia Fractures. Orthopedics. 2016 Nov 1;39(6):e1117-e1123. doi: 10.3928/01477447-20160819-01. Epub 2016 Aug 30.
Whelan DB, Bhandari M, Stephen D, Kreder H, McKee MD, Zdero R, Schemitsch EH
Development of the radiographic union score for tibial fractures for the assessment of tibial fracture healing after intramedullary fixation. J Trauma. 2010 Mar;68(3):629-32. doi: 10.1097/TA.0b013e3181a7c16d.

Primary Dynamization Versus Standard Interlocking Intramedullary Nail in Treatment of Tibial Shaft Fractures in Adults

Clinical trial NCT06147219 - References