Clinical trial NCT01944345: Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device
Official title: VariLift Lumbar and Cervical Patient Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolapsed Lumbar Disc
Prolapsed Cervical Disc
Intervertebral Disc Degeneration
Spondylolisthesis, Grade 1
Intervertebral Disc Displacement
Lead sponsor: Wenzel Spine
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50
timeFrame: Pre-operative and Post-operative 12 months post-operative
measure: Change in VAS Pain
timeFrame: Pre-operative and Post-operative 12 months
Secondary outcomes:
measure: Radiological Assessment
timeFrame: Post-operative follow up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: San Antonio
country: United States
facility: Foundation Surgical Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Warren Neely, MD
role: PRINCIPAL_INVESTIGATOR
References: