Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Prolapsed Cervical Disc, Prolapsed Lumbar Disc, Spondylolisthesis, Grade 1
Conditions
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
Wenzel Spine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 | Pre-operative and Post-operative 12 months post-operative | 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 |
| Change in VAS Pain | Pre-operative and Post-operative 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Radiological Assessment | Post-operative follow up | Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated |
Countries
United States
Participant flow
Recruitment details
Multi-site recruitment with up to 1000 patients to be enrolled for entire study across all hospital or ASC sites.
Participants by arm
| Arm | Count |
|---|---|
| Registry Patients Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting. | 69 |
| Total | 69 |
Baseline characteristics
| Characteristic | Registry Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Age, Continuous | 60 years |
| BMI < 40kg/m^2 | 69 participants |
| Region of Enrollment United States | 69 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 69 |
| serious Total, serious adverse events | 0 / 69 |
Outcome results
Primary
Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50
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
Time frame: Pre-operative and Post-operative 12 months post-operative
Population: Combined cervical and lumbar patients: 30 cervical, 39 lumbar. Mean ODI/NDI was calculated for all patients at preop and 12 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Registry Patients | Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 | NDI Score Pre-Surgery | 20.07 Units on a scale 0-50 | Standard Deviation 9.37 |
| Registry Patients | Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 | NDI Score at 12 Months | 5.61 Units on a scale 0-50 | Standard Deviation 8.15 |
| Registry Patients | Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 | ODI Score at Pre-Surgery | 19.27 Units on a scale 0-50 | Standard Deviation 5.33 |
| Registry Patients | Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 | ODI Score at 12 Months | 10.41 Units on a scale 0-50 | Standard Deviation 7.2 |
Primary
Change in VAS Pain
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'
Time frame: Pre-operative and Post-operative 12 months
Population: Total subjects: 30 Cervical subjects, 39 Lumbar subjects. VAS PAIN SEVERITY SCALE ranges from 0-10. Zero = no pain, 10 - worst imaginable pain
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Registry Patients | Change in VAS Pain | Cervical Preoperative | 3.53 Units on a scale 0-10 | Standard Deviation 1.01 |
| Registry Patients | Change in VAS Pain | Cervical Postoperative | 1.03 Units on a scale 0-10 | Standard Deviation 0.38 |
| Registry Patients | Change in VAS Pain | Lumbar Preoperative | 5.85 Units on a scale 0-10 | Standard Deviation 0.49 |
| Registry Patients | Change in VAS Pain | Lumbar Postoperative | 2.16 Units on a scale 0-10 | Standard Deviation 0.25 |
Secondary
Radiological Assessment
Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated
Time frame: Post-operative follow up
Population: 26 (of 30) Cervical Patients 30 (of 39) Lumbar Patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Registry Patients | Radiological Assessment | Cervical Fusion at 12M | 26 participants |
| Registry Patients | Radiological Assessment | Cervical Subsidence/Migration (>3mm) | 0 participants |
| Registry Patients | Radiological Assessment | Lumbar Fusion at 12M | 29 participants |
| Registry Patients | Radiological Assessment | Lumbar Subsidence/Migration (>3mm) | 1 participants |