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

NCT01944345 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 69

Last updated 2016-05-17

Study results available
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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.

Conditions

  • Prolapsed Lumbar Disc
  • Prolapsed Cervical Disc
  • Intervertebral Disc Degeneration
  • Spondylolisthesis, Grade 1
  • Intervertebral Disc Displacement

Sponsors & Collaborators

  • Wenzel Spine

    lead INDUSTRY

Principal Investigators

  • Warren Neely, MD · The Methodist Hospital Research Institute

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01944345 on ClinicalTrials.gov