NCT05347056 - 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)

Baroncini A, Trobisch PD, Berrer A, Kobbe P, Tingart M, Eschweiler J, Da Paz S, Migliorini F
Return to sport and daily life activities after vertebral body tethering for AIS: analysis of the sport activity questionnaire. Eur Spine J. 2021 Jul;30(7):1998-
Green DW, Lawhorne TW 3rd, Widmann RF, Kepler CK, Ahern C, Mintz DN, Rawlins BA, Burke SW, Boachie-Adjei O
Long-term magnetic resonance imaging follow-up demonstrates minimal transitional level lumbar disc degeneration after posterior spine fusion for adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2011 Nov 1;36(23):1948-54. doi: 10.1097/BRS.0b013e3181ff1ea9.
Kim HJ, Yang JH, Chang DG, Suk SI, Suh SW, Nam Y, Kim SI, Song KS
Long-Term Influence of Paraspinal Muscle Quantity in Adolescent Idiopathic Scoliosis Following Deformity Correction by Posterior Approach. J Clin Med. 2021 Oct 19;10(20). pii: 4790. doi: 1
Pehlivanoglu T, Oltulu I, Erdag Y, Akturk UD, Korkmaz E, Yildirim E, Sarioglu E, Ofluoglu E, Aydogan M
Comparison of clinical and functional outcomes of vertebral body tethering to posterior spinal fusion in patients with adolescent idiopathic scoliosis

The Effect of Vertebral Body Tethering on Lumbar Paraspinal Muscle Cross-Section Area, Lumbar Range of Motion and Trunk Muscle Strength in Adolescent Idiopathic Scoliosis

Details for clinical trial NCT05347056

Clinical trial NCT05347056 - References