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

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.

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Key information

Conditions

Prolapsed Lumbar Disc Bone Diseases Hemic and Lymphatic Diseases Hernia Immune System Diseases Immunoproliferative Disorders Intervertebral Disc Degeneration Intervertebral Disc Displacement Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapsed Cervical Disc Spinal Diseases Spondylolisthesis Spondylolisthesis, Grade 1 Spondylolysis Spondylosis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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
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 outcomes

Radiological Assessment

Time frame: Post-operative follow up

Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated

Sponsors and collaborators

Lead sponsor

Wenzel Spine

Industry

Registry information

Official study title

VariLift Lumbar and Cervical Patient Registry

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Sep 17, 2013
Registry last updated: May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed