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

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.

Study Overview

• Status: Completed
• Conditions: Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spondylolisthesis, Grade 1; Prolapsed Lumbar Disc; Prolapsed Cervical Disc

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
    • San Antonio, Texas, United States, 78229
      • Foundation Surgical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing spinal fusion using VariLift lumbar or cervical devices must be screened by the investigating surgeon for eligibility into the registry using the primary diagnosis parameters and the inclusion/exclusion criteria. In addition physicians must follow the associated VariLift Instructions for Use.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wenzel Spine
• Investigators: Principal Investigator: Warren Neely, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 17, 2013

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Spondylolysis; Spondylosis; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: 2012-001, Ver3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared