MLX/XLX ACR Expandable Lumbar Interbody Implants
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Degenerative Disc Disease
- Degenerative Scoliosis
- Spondylolisthesis
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Retrospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 with surgeries that meet eligibility requirements will be included in the study and available progress notes, medic...
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: Complications attributable to the use of the associated interbody implant as noted in surgical summaries, progress notes, and hospital records Neurologic status, symptoms, and subject self-reported clinical outcomes (e.g., pain and disability), as available Radiographic outcome (fusion) and description of device status from plain film radiographs and computed tomography (CT) scan(s), as available
Tracking Information
- NCT #
- NCT04420143
- Collaborators
- Not Provided
- Investigators
- Study Director: Kyle Malone, MS NuVasive