N/A
Completed N=69
Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device
Prolapsed Lumbar Disc · Prolapsed Cervical Disc · intervertebral disc degeneration · Spondylolisthesis, Grade 1
Source: ClinicalTrials.gov NCT01944345 ↗
Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 — 20.07; 5.61; 19.27; 10.41 Units on a scale 0-50
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 |
20.07; 5.61; 19.27; 10.41 | — |
| PRIMARY Change in VAS Pain |
3.53; 1.03; 5.85; 2.16 | — |
| SECONDARY Radiological Assessment |
26; 0; 29; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01944345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.