NCT02068729 - 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)

Berjano P, Balsano M, Buric J, Petruzzi M, Lamartina C
Direct lateral access lumbar and thoracolumbar fusion: preliminary results. Eur Spine J. 2012 May;21 Suppl 1:S37-42. doi: 10.1007/s00586-012-2217-z. Epub 2012 Mar 9.
Caputo AM, Michael KW, Chapman TM Jr, Massey GM, Howes CR, Isaacs RE, Brown CR
Clinical outcomes of extreme lateral interbody fusion in the treatment of adult degenerative scoliosis. ScientificWorldJournal. 2012;2012:680643. doi: 10.1100/2012/680643. Epub 2012 Sep 24.
Malham GM, Ellis NJ, Parker RM, Seex KA
Clinical outcome and fusion rates after the first 30 extreme lateral interbody fusions. ScientificWorldJournal. 2012;2012:246989. doi: 10.1100/2012/246989. Epub 2012 Nov 1.
Youssef JA, McAfee PC, Patty CA, Raley E, DeBauche S, Shucosky E, Chotikul L
Minimally invasive surgery: lateral approach interbody fusion: results and review. Spine (Phila Pa 1976). 2010 Dec 15;35(26 Suppl):S302-11. doi: 10.1097/BRS.0b013e3182023438.

A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®

Clinical trial NCT02068729 - References