Degenerative Disc Disease Clinical Trial
Official title:
An Assessment of the Safety and Performance of the Modulus® 3D-printed Titanium Interbody Implant in Patients Undergoing eXtreme Lateral Interbody Fusion (XLIF®)
The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF 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 asked to consent to participate in the study. Once enrolled in the study, subjects will undergo a computed tomography (CT) scan at 12 months postoperative or later to evaluate their fusion status. If the patient already had a postoperative CT scan at 12 months or greater, this will be used in this study and an additional CT scan should not be performed for this 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 safety and performance of the Modulus XLIF interbody implant will be assessed using the following: 1. Complications attributable to the use of the Modulus XLIF interbody implant as noted in surgical summaries, progress notes, and hospital records 2. Radiographic outcome (fusion) and description of device status from plain film radiographs and CT scan(s) 3. Neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available ;
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