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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre-operative and Post-operative 12 months post-operative |
| 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' | Pre-operative and Post-operative 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological Assessment | Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated | Post-operative follow up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing spinal fusion using VariLift lumbar or cervical devices must be screened by the investigating surgeon for eligibility into the registry using the primary diagnosis parameters and the inclusion/exclusion criteria. In addition physicians must follow the associated VariLift Instructions for Use.
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| Name | Affiliation | Role |
|---|---|---|
| Warren Neely, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Foundation Surgical Hospital |
Data will not be shared
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Multi-site recruitment with up to 1000 patients to be enrolled for entire study across all hospital or ASC sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Registry Patients | Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| San Antonio |
| Texas |
| 78229 |
| United States |
| Methodist Hospital | San Antonio | Texas | 78229 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Registry Patients | Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| BMI < 40kg/m^2 | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Combined cervical and lumbar patients: 30 cervical, 39 lumbar. Mean ODI/NDI was calculated for all patients at preop and 12 month. | Posted | Mean | Standard Deviation | Units on a scale 0-50 | Pre-operative and Post-operative 12 months post-operative |
|
|
| |||||||||||||||||||||||||||||||||||
| 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' | Total subjects: 30 Cervical subjects, 39 Lumbar subjects. VAS PAIN SEVERITY SCALE ranges from 0-10. Zero = no pain, 10 - worst imaginable pain | Posted | Mean | Standard Deviation | Units on a scale 0-10 | Pre-operative and Post-operative 12 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Radiological Assessment | Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated | 26 (of 30) Cervical Patients 30 (of 39) Lumbar Patients | Posted | Number | participants | Post-operative follow up |
|
|
Preoperative versus 12 months Postoperative
Events were assessed with each follow-up appointment and as reported by participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Registry Patients | Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting. | 0 | 69 | 22 | 69 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Not Device Related | Social circumstances | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Quality & Regulatory Affairs | Wenzel Spine, Inc. | 5123148271 | bnowatzke@wenzelspine.com |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| D008224 | Lymphoma, Follicular |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
|
| ODI Score at 12 Months |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Cervical Fusion at 12M |
| |||||
| Cervical Subsidence/Migration (>3mm) |
| |||||
| Lumbar Fusion at 12M |
| |||||
| Lumbar Subsidence/Migration (>3mm) |
|