NCT04420143

MLX/XLX ACR Expandable Lumbar Interbody Implants

An Assessment of the Safety and Performance of the MLX® Medial Lateral and XLX ACR® Expandable Lumbar Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Thoracic and/or Lumbar Spine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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 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

Conditions

• Degenerative Disc Disease
• Spondylolisthesis
• Degenerative Scoliosis

Timeline

• Start date: 2020-01-27
• Primary completion: 2020-10-23
• Completion: 2020-10-23
• First posted: 2020-06-09
• Last updated: 2025-12-22

Locations

4 sites across 1 country: United States