Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device
Completed
Conditions studied: Prolapsed Lumbar Disc, Prolapsed Cervical Disc, Intervertebral Disc Degeneration, Spondylolisthesis, Grade 1, Intervertebral Disc Displacement
In brief
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.
Key facts
- Study ID
- NCT01944345
- Run by
- Wenzel Spine
- People needed
- 69
- Starts
- 2013-06-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2016-05-17
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Foundation Surgical Hospital — San Antonio, Texas, United States
- Methodist Hospital — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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