NCT02998333 - 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)

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Sprained ankles. VI. Surgical treatment of "chronic" ligament ruptures. Acta Chir Scand. 1966 Nov;132(5):551-65.
Drakos MC, Behrens SB, Paller D, Murphy C, DiGiovanni CW
Biomechanical Comparison of an Open vs Arthroscopic Approach for Lateral Ankle Instability. Foot Ankle Int. 2014 Aug;35(8):809-815. Epub 2014 May 21.
Kobayashi T, Gamada K
Lateral Ankle Sprain and Chronic Ankle Instability: A Critical Review. Foot Ankle Spec. 2014 Aug 1;7(4):298-326. Epub 2014 Jun 24. Review.
Mabit, C
C., J.M.; Fiorenza, F.; Huc, H.; Pecout, C., Lateral ligament reconstruction of the ankle: comparative study of peroneus brevis tenodesis versus periosteal ligamentoplasty. Foot and Ankle Surgery, 1998. 4(2): p. 6.
Matsui K, Takao M, Miyamoto W, Matsushita T
Early recovery after arthroscopic repair compared to open repair of the anterior talofibular ligament for lateral instability of the ankle. Arch Orthop Trauma Surg. 2016 Jan;136(1):93-100. Epub 2015 Oct 14.
Pereira H, Vuurberg G, Gomes N, Oliveira JM, Ripoll PL, Reis RL, Espregueira-Mendes J, Niek van Dijk C
Arthroscopic Repair of Ankle Instability With All-Soft Knotless Anchors. Arthrosc Tech. 2016 Feb 1;5(1):e99-e107. doi: 10.1016/j.eats.2015.10.010. eCollection 2016 Feb.

Does Arthroscopic Anatomic Repair of the Anterior Talofibular Ligament Provide Better Functional Outcome Compared to Open Anatomic Repair in Patients With Chronic Ankle Instability: a Multicentre Randomized Controlled Trial

Details for clinical trial NCT02998333

Clinical trial NCT02998333 - References