NCT04590807 - 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)

Newton PO, Bartley CE, Bastrom TP, Kluck DG, Saito W, Yaszay B
Anterior Spinal Growth Modulation in Skeletally Immature Patients with Idiopathic Scoliosis: A Comparison with Posterior Spinal Fusion at 2 to 5 Years Postoperatively. J Bone Joint Surg Am. 2
Newton PO, Kluck DG, Saito W, Yaszay B, Bartley CE, Bastrom TP
Anterior Spinal Growth Tethering for Skeletally Immature Patients with Scoliosis: A Retrospective Look Two to Four Years Postoperatively. J Bone Joint Surg Am. 2018 Oct 3;100(19):1691-1697. d
Wong HK, Ruiz JNM, Newton PO, Gabriel Liu KP
Non-Fusion Surgical Correction of Thoracic Idiopathic Scoliosis Using a Novel, Braided Vertebral Body Tethering Device: Minimum Follow-up of 4 Years. JB JS Open Access. 2019 Dec 12;4(4):e0026. doi: 10.2106/JBJ

Posterior Spinal Fusion With Pedicle Screws vs. Anterior Vertebral Body Tethering in Adolescent Idiopathic Scoliosis (AIS): an International Multicenter Randomized Clinical Trial

Details for clinical trial NCT04590807

Clinical trial NCT04590807 - References