NCT04641039 - 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)

Auerbach JD, Jones KJ, Milby AH, Anakwenze OA, Balderston RA
Segmental contribution toward total lumbar range of motion in disc replacement and fusions: a comparison of operative and adjacent levels. Spine (Phila Pa 1976). 2009 Nov 1;34(23):2510-7. doi: 10.1097/BRS.0b013e3181af2622.
Frelinghuysen P, Huang RC, Girardi FP, Cammisa FP Jr
Lumbar total disc replacement part I: rationale, biomechanics, and implant types. Orthop Clin North Am. 2005 Jul;36(3):293-9. doi: 10.1016/j.ocl.2005.02.014.
Huang YJ, Zhao SJ, Zhang Q, Nong LM, Xu NW
Comparison of lumbar pedicular dynamic stabilisation systems versus fusion for the treatment of lumbar degenerative disc disease: A meta-analysis. Acta Orthop Belg. 2017 Mar;83(1):180-193.

Effect of the Postoperative Prevertebral Scar on Controlling Excess After Removing the Anterior Lumbar Disc Annulus Fibrosus to Implant a Lumbar Disc Prosthesis. Biomechanical and Clinical Study

Details for clinical trial NCT04641039

Clinical trial NCT04641039 - References