NCT06313177 - 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)

Cornu O, Manon J, Tribak K, Putineanu D
Traumatic injuries of the distal tibiofibular syndesmosis. Orthop Traumatol Surg Res. 2021 Feb;107(1S):102778. doi: 10.1016/j.otsr.2020.102778. Epub 2020 Dec 14.
Corte-Real N, Caetano J
Ankle and syndesmosis instability: consensus and controversies. EFORT Open Rev. 2021 Jun 28;6(6):420-431. doi: 10.1302/2058-5241.6.210017. eCollection 2021 Jun.
Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M
Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. doi: 10.1177/107110079401500701.
van Zuuren WJ, Schepers T, Beumer A, Sierevelt I, van Noort A, van den Bekerom MPJ
Acute syndesmotic instability in ankle fractures: A review. Foot Ankle Surg. 2017 Sep;23(3):135-141. doi: 10.1016/j.fas.2016.04.001. Epub 2016 Apr 25.

Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in Ankle Fractures; Comparative Study.

Clinical trial NCT06313177 - References