NCT01865942 - 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)

Falicov A, Fisher CG, Sparkes J, Boyd MC, Wing PC, Dvorak MF
Impact of surgical intervention on quality of life in patients with spinal metastases. Spine (Phila Pa 1976). 2006 Nov 15;31(24):2849-56.
Kim KT, Lee SH, Suk KS, Bae SC
The quantitative analysis of tissue injury markers after mini-open lumbar fusion. Spine (Phila Pa 1976). 2006 Mar 15;31(6):712-6.
Ringel F, Stoffel M, Stüer C, Meyer B
Minimally invasive transmuscular pedicle screw fixation of the thoracic and lumbar spine. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS361-6; discussion ONS366-7.
Rodríguez-Vela J, Lobo-Escolar A, Joven-Aliaga E, Herrera A, Vicente J, Suñén E, Loste A, Tabuenca A
Perioperative and short-term advantages of mini-open approach for lumbar spinal fusion. Eur Spine J. 2009 Aug;18(8):1194-201. doi: 10.1007/s00586-009-1010-0. Epub 2009 Apr 28.

Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A Randomized Clinical Trial.

Clinical trial NCT01865942 - References