Intervertebral Disc Degeneration Clinical Trial
Official title:
VariLift Lumbar and Cervical Patient Registry
The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and improved patient care. All patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the VariLift device. Potential treatment procedures include bilateral posterior lumbar interbody fusion (PLIF), unilateral transforaminal lumbar interbody fusion (TLIF), or bilateral anterior lumbar interbody fusion (ALIF) for the lumbar spine, or cervical unilateral or bilateral ACDF procedure. Surgical procedures can be performed in either an inpatient or outpatient facility. It is anticipated that the VariLift devices will improve patient outcomes and lead to the development of treatment pathways to improve patient care.
The registry is design to collect data prospectively on patients undergoing spinal fusion
using the VariLift-L, VariLift-A, or VariLift-C device patients will be enrolled in the
registry after reviewing the protocol with their health care provider and signing the
informed consent. Data will be collected at recommended time points based on the standards
of care of the participating sites. The registry will serve as a database in which
retrospective analysis and exploratory analysis of specific research questions will be
answered.
Follow up visits will be defined by the treating physicians based on their standard
practice. Typical clinical follow up schedules for patients undergoing this type of surgery
are pre-operative, immediate post-op, 3, 6, and 12 months post-operative.
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Observational Model: Case-Only, Time Perspective: Prospective
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