Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 6:46 PM
Study NCT ID:
NCT05566704
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2022-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Modulus ALIF Study
Sponsor:
NuVasive
Organization:
Study Overview
Official Title:
An Assessment of the Safety and Performance of the Modulus® ALIF System in Patients Undergoing Anterior Lumbar Interbody Fusion
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: