Degenerative Disc Disease Clinical Trial
Official title:
An Assessment of the Safety and Performance of the Modulus® ALIF System in Patients Undergoing Anterior Lumbar Interbody Fusion
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: 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 ;
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