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

Wenzel Spine

Status: Completed

Conditions: Prolapsed Lumbar Disc; Intervertebral Disc Degeneration; Prolapsed Cervical Disc; Spondylolisthesis, Grade 1; Intervertebral Disc Displacement

Study type: Observational

Funder types: Industry

Identifiers

NCT01944345

2012-001, Ver3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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