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



Status:Completed
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:June 2013
End Date:September 2015

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VariLift Lumbar and Cervical Patient Registry

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.

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.

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
We found this trial at
3
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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San Antonio, Texas
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San Antonio, Texas 78229
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