Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
123 participants
OBSERVATIONAL
2022-08-18
2024-05-01
Brief Summary
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Detailed Description
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The complication profile and overall performance of the Modulus ALIF System will be assessed using the following:
1. Complications attributable to the use of the Modulus ALIF System as noted in surgical summaries, progress notes, and hospital records; and
2. Radiographic outcome (fusion) and description of device status from available plain film radiographs and CT scan(s); and
3. Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Modulus ALIF System
Modulus ALIF System
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.
Interventions
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Modulus ALIF System
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.
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients who are ≥18 years of age at the time of surgery
3. 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
4. Treated with ALIF procedure with the Modulus ALIF System at:
* One or two adjacent lumbar and/or lumbosacral levels for degenerative disc disease (DDD), degenerative spondylolisthesis, or spinal stenosis, or
* Any number of lumbar and/or lumbosacral levels for degenerative scoliosis (defined as \>10º coronal curve) or sagittal deformity
5. Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria:
* 1-2 levels treated for DDD, and
* 3 or 4 interfixated screws placed, and
* Implant lordosis is ≤20°
Exclusion Criteria
2. Patient was participating in another clinical study during treatment that would confound study data
18 Years
ALL
No
Sponsors
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NuVasive
INDUSTRY
Responsible Party
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Principal Investigators
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Kyle Malone, MS
Role: STUDY_DIRECTOR
Globus Medical
Locations
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Hoag Orthopedics
Orange, California, United States
Girard Orthopedic Surgeons
San Diego, California, United States
Georgia Spine & Neurosurgery Center
Atlanta, Georgia, United States
OrthoCarolina
Charlotte, North Carolina, United States
Atlantic Brain and Spine
Wilmington, North Carolina, United States
Countries
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Other Identifiers
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NUVA.RMA0222
Identifier Type: -
Identifier Source: org_study_id