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The primary objective of this study is to evaluate the safety and performance of the Modulus ALIF System in patients undergoing anterior lumbar interbody fusion (ALIF) as measured by reported complications, radiographic outcomes, and patient-reported outcomes.
Patients considered for this study will have previously undergone surgery for their spinal condition according to the standard of care of the practitioner. All patients at a given site who meet eligibility requirements will be considered for participation in the study. Available progress notes, medical records, patient-reported outcomes, radiographs (plain film and CT scans, if available), and complications will be obtained from the medical records of all enrolled subjects.
The complication profile and overall performance of the Modulus ALIF System will be assessed using the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modulus ALIF System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modulus ALIF System | Device | The Modulus ALIF System is designed to address lumbar pathologies utilizing interbody placement through an anterior or anterolateral surgical approach. The Modulus ALIF System is an interfixated interbody system available in various shapes and sizes to suit the individual pathology and anatomical conditions of the patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of complications attributable to the use of the Modulus ALIF System | 12 months | |
| Proportion of subjects with apparent radiographic fusion at 6 months or greater postoperative | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available | 12 months |
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Inclusion Criteria:
Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery
Male or female patients who are ≥18 years of age at the time of surgery
Had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the Modulus ALIF system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome
Treated with ALIF procedure with the Modulus ALIF System at:
Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:
Exclusion Criteria:
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The analysis population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Malone, MS | Globus Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Orthopedics | Orange | California | 92868 | United States | ||
| Girard Orthopedic Surgeons |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013168 | Spondylolisthesis |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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|
| San Diego |
| California |
| 92121 |
| United States |
| Georgia Spine & Neurosurgery Center | Atlanta | Georgia | 30342 | United States |
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States |
| Atlantic Brain and Spine | Wilmington | North Carolina | 28401 | United States |
| D055009 |
| Spondylosis |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |