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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wenzel Spine
ClinicalTrials.gov Identifier:
NCT01944345
First received: September 6, 2013
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
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
Prolapsed Lumbar Disc
Prolapsed Cervical Disc
Intervertebral Disc Degeneration
Spondylolisthesis, Grade 1
Intervertebral Disc Displacement

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: VariLift Lumbar and Cervical Patient Registry

Resource links provided by NLM:


Further study details as provided by Wenzel Spine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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:
  • Radiological Assessment [ Time Frame: Post-operative follow up ] [ Designated as safety issue: No ]
    Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated


Enrollment: 69
Study Start Date: June 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944345

Locations
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
Principal Investigator: Warren Neely, MD The Methodist Hospital System
  More Information

Responsible Party: Wenzel Spine
ClinicalTrials.gov Identifier: NCT01944345     History of Changes
Other Study ID Numbers: 2012-001, Ver3 
Study First Received: September 6, 2013
Results First Received: January 6, 2016
Last Updated: April 14, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Spondylolisthesis
Bone Diseases
Hernia
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on May 30, 2016