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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Wenzel Spine
Sponsor:
Information provided by (Responsible Party):
Wenzel Spine
ClinicalTrials.gov Identifier:
NCT01944345
First received: September 6, 2013
Last updated: December 10, 2013
Last verified: December 2013
  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
Decreased Disc Height

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: VariLift Lumbar and Cervical Patient Registry

Further study details as provided by Wenzel Spine:

Primary Outcome Measures:
  • Change in Oswestry Disability Index/Neck Disability Index [ Time Frame: Pre-operative vs. Post-operative 6 weeks, 3, 6, and 12 months post-operative ] [ Designated as safety issue: No ]
  • Change in VAS Pain [ Time Frame: Pre-operative vs. Post-operative 6 weeks, 3, 6, 12 months ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 1000
Study Start Date: June 2013
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Risa Tyo (214) 729-7807 rtyo@dc2healthcare.com
Contact: Sandie Roth 512-501-4022 sroth@wenzelspine.com

Locations
United States, Alabama
St. Vincent's Hospital Recruiting
Birmingham, Alabama, United States
Contact: Philley         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States
Contact: Lee         
United States, Texas
Methodist Hospital Recruiting
San Antonio, Texas, United States
Contact: Eaton         
Foundation Surgical Hospital Recruiting
San Antonio, Texas, United States
Contact: Eaton         
Sponsors and Collaborators
Wenzel Spine
  More Information

No publications provided

Responsible Party: Wenzel Spine
ClinicalTrials.gov Identifier: NCT01944345     History of Changes
Other Study ID Numbers: 2012-001, Ver3
Study First Received: September 6, 2013
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014