The objective of this study is to evaluate the safety and performance of thoracic and/or lumbar spine surgery using the MLX and XLX ACR interbody implants as measured by reported complications, radiographic outcomes, and clinical patient outcomes. This study is being undertaken to identify possible residual risks and to clarify mid- to long-term clinical performance that may affect the benefit/risk ratios of the MLX and XLX ACR interbody implants.
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 with surgeries that meet eligibility requirements will be included in the study and available progress notes, medical records, patient-reported outcomes (PROs), radiographs, and complications will be obtained from the medical records. The safety and performance of the MLX and XLX ACR interbody implants will be assessed using the following: 1. Complications attributable to the use of the associated interbody implant as noted in surgical summaries, progress notes, and hospital records 2. Neurologic status, symptoms, and subject self-reported clinical outcomes (e.g., pain and disability), as available 3. Radiographic outcome (fusion) and description of device status from plain film radiographs and computed tomography (CT) scan(s), as available
Study Type
OBSERVATIONAL
Enrollment
109
Orthopaedic Specialty Institute
Orange, California, United States
Lyerly Neurosurgery
Jacksonville, Florida, United States
Carolina NeuroSurgery & Spine Associates
Charlotte, North Carolina, United States
OrthoCarolina Research Institute
Charlotte, North Carolina, United States
Rate of Complications
Rate of complications (i.e., safety) attributable to use of the associated interbody implants (MLX or XLX ACR)
Time frame: At least three months
Proportion of Subjects with Improvement in Neurological Symptoms
The rate of improvement as compared to baseline in preoperative neurological symptoms will be measured using a standard motor/sensory neurological exam.
Time frame: At least three months
Proportion of Subjects with Apparent Radiographic Fusion
Proportion of subjects with apparent radiographic fusion at 12 months or greater postoperative, as imaging is available
Time frame: 12 months or greater
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