CompletedNot Applicable

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

United States69 participantsStarted 2013-06

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50

Timeframe: Pre-operative and Post-operative 12 months post-operative

Change in VAS Pain

Timeframe: Pre-operative and Post-operative 12 months

Trial details

NCT IDNCT01944345

SponsorWenzel Spine

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-09

Results submitted2016-01-06

View on ClinicalTrials.gov More Prolapsed Lumbar Disc trials