Clinical trial · Observational
Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device
VariLift Lumbar and Cervical Patient Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intervertebral Disc Degeneration | — | UNRESOLVED | — |
| Intervertebral Disc Displacement | — | UNRESOLVED | — |
| Prolapsed Cervical Disc | — | UNRESOLVED | — |
| Prolapsed Lumbar Disc | — | UNRESOLVED | — |
| Spondylolisthesis, Grade 1 | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50
- timeFrame
- Pre-operative and Post-operative 12 months post-operative
- description
- ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability \>34 Complete disability
- measure
- Change in VAS Pain
- timeFrame
- Pre-operative and Post-operative 12 months
- description
- VAS Pain comparison Preoperative vs post-operative of greater than or equal to 6. VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means 'no pain' and a ten (10) means 'worst imaginable pain'
Secondary outcomes (1)
- measure
- Radiological Assessment
- timeFrame
- Post-operative follow up
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available