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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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VariLift Lumbar and Cervical Patient Registry

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

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is undergoing a procedure with unilateral or bilateral placement of VariLift This is the first surgery at the index level Patient has understood and signed the informed consent Patient is skeletally mature Exclusion Criteria: Revision Surgery Is a Worker's Compensation Case Infection at the operative site Sustained trauma with instability Sustained fracture of the vertebra at any of the lumbar spinal levels Has a primary diagnosis of degenerative or isthmic spondylolisthesis greater than Grade 1 Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or drug abuse) Has a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the clinical study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy, metastasis to vertebrae, adult onset diabetes, active rheumatoid arthritis, etc.) Is an immunologically suppressed or receiving steroid in excess of usual doses Is obese (as defined by a Body Mass Index (BMI) of > 40 kg/m2 (BMI equals (weight in pounds x 703) / (height in inches x height in inches)) Has disabling and daily narcotic dependency greater than 18 months Has a known malignancy Has a known allergy to metal implants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 | 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 | Pre-operative and Post-operative 12 months post-operative | 
| Change in VAS Pain | 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' | Pre-operative and Post-operative 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological Assessment | Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated | Post-operative follow up |