Other Clinical Trial - PRESTIGE® Cervical Disc Study

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.

Clinical Trial Summary

The purpose of this clinical investigation is to evaluate the safety and effectiveness of the ACD in the single level surgical treatment of patients with symptomatic cervical degenerative disc disease. The primary follow-up information obtained from this clinical investigation are used to support a PMA application for the ACD.

See also
Status	Clinical Trial	Phase
Completed	`NCT01491399` - INFUSE™ BONE GRAFT/CORNERSTONE-SR™ Allograft Ring/ATLANTIS™ Anterior Cervical Plate- Pilot Study	N/A
Completed	`NCT00875810` - PRESTIGE Observational Study	N/A
Terminated	`NCT01491477` - INFUSE ® Bone Graft/CORNERSTONE-SR® Allograft Ring/ATLANTIS® Anterior Cervical Plate System Pivotal Trial	N/A

NCT number	NCT00642876
Study type	Interventional
Source	Medtronic Spinal and Biologics
Contact
Status	Completed
Phase	N/A
Start date	October 2002
Completion date	May 2013

PRESTIGE® Cervical Disc Study

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms