Clinical Trial: Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

Official Title: VariLift Lumbar and Cervical Patient Registry

Brief Summary: 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.

Detailed Summary:

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 and 12 months post-operative.


Sponsor: Wenzel Spine

Current Primary Outcome:

  • Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 [ Time Frame: Pre-operative and Post-operative 12 months post-operative ]
    ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability >34 Complete disability
  • Change in VAS Pain [ Time Frame: Pre-operative and Post-operative 12 months ]

    VAS Pain comparison Preoperative vs post-operative of greater than or equal to 6.

    VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means 'no pain' and a ten (10) means 'worst imaginable pain'



Original Primary Outcome:

  • Change in Oswestry Disability Index/Neck Disability Index [ Time Frame: Pre-operative vs. Post-operative 6 weeks, 3, 6, and 12 months post-operative ]
  • Change in VAS Pain [ Time Frame: Pre-operative vs. Post-operative 6 weeks, 3, 6, 12 months ]


Current Secondary Outcome: Radiological Assessment [ Time Frame: Post-operative follow up ]

Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated


Original Secondary Outcome: Radiological Assessment [ Time Frame: Post-operative follow up ]

Determination of fusion assessment, subsidence or migration of the device.


Information By: Wenzel Spine

Dates:
Date Received: September 6, 2013
Date Started: June 2013
Date Completion:
Last Updated: April 14, 2016
Last Verified: April 2016