NCT06020417 - 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)

Perdomo-Pantoja A, Ishida W, Zygourakis C, Holmes C, Iyer RR, Cottrill E, Theodore N, Witham TF, Lo SL
Accuracy of Current Techniques for Placement of Pedicle Screws in the Spine: A Comprehensive Systematic Review and Meta-Analysis of 51,161 Screws. World Neurosurg. 2019 Jun;126:664-678.e3. doi: 10.1016/j.wneu.2019.02.217. Epub 2019 Mar 15.
Santos ER, Ledonio CG, Castro CA, Truong WH, Sembrano JN
The accuracy of intraoperative O-arm images for the assessment of pedicle screw postion. Spine (Phila Pa 1976). 2012 Jan 15;37(2):E119-25. doi: 10.1097/BRS.0b013e3182257cae.

Occurrence of Pedicle Screw Malposition in Spine Arthrodesis Surgeries Performed With O-ARM-guided Navigation at a University Hospital: a Randomized Controlled Trial

Details for clinical trial NCT06020417

Clinical trial NCT06020417 - References