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

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ClinicalTrials.gov Identifier: NCT01944345
Recruitment Status : Completed
First Posted : September 17, 2013
Results First Posted : April 14, 2016
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Wenzel Spine

Study Description
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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.

Condition or disease
Prolapsed Lumbar Disc Prolapsed Cervical Disc Intervertebral Disc Degeneration Spondylolisthesis, Grade 1 Intervertebral Disc Displacement

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 69 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: VariLift Lumbar and Cervical Patient Registry
Study Start Date : June 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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'



Secondary Outcome Measures :
  1. Radiological Assessment [ Time Frame: Post-operative follow up ]
    Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944345


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Texas
Foundation Surgical Hospital
San Antonio, Texas, United States, 78229
Methodist Hospital
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Wenzel Spine
Investigators
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Principal Investigator: Warren Neely, MD The Methodist Hospital Research Institute
More Information
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Additional Information:

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Responsible Party: Wenzel Spine
ClinicalTrials.gov Identifier: NCT01944345    
Other Study ID Numbers: 2012-001, Ver3
First Posted: September 17, 2013    Key Record Dates
Results First Posted: April 14, 2016
Last Update Posted: May 17, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared
Additional relevant MeSH terms:
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Spondylolisthesis
Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Spondylolysis
Spondylosis
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical