NCT01342588 - 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)

Collado-Corona MA, de Leo-Vargas R, Sandoval-Sánchez V, Díaz-Hernández A, Gutiérrez-Sougarret BJ, Shkurovich-Bialik P
Neurophysiological monitoring in spinal cord surgery. Cir Cir. 2009 Sep-Oct;77(5):385-90.
Donohue ML, Murtagh-Schaffer C, Basta J, Moquin RR, Bashir A, Calancie B
Pulse-train stimulation for detecting medial malpositioning of thoracic pedicle screws. Spine (Phila Pa 1976). 2008 May 20;33(12):E378-85. doi: 10.1097/BRS.0b013e31817343c1.
Roy-Camille R, Saillant G, Mazel C
Internal fixation of the lumbar spine with pedicle screw plating. Clin Orthop Relat Res. 1986 Feb;(203):7-17.
Welch WC, Rose RD, Balzer JR, Jacobs GB
Evaluation with evoked and spontaneous electromyography during lumbar instrumentation: a prospective study. J Neurosurg. 1997 Sep;87(3):397-402.

Accuracy of Lumbar Pedicle Screw Placement Assisted With Continuous Pulse-train Stimulation During Track Creation and Screw Insertion

Clinical trial NCT01342588 - References