NCT04418830

Lumbar Interbody Implant Study

A Prospective, Multicenter Study Evaluating the Safety and Performance of Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Thoracic and/or Lumbar Spine

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,050 (estimated)
• 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 NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and patient-reported 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 these interbody implants.

Detailed description

This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select interbody implant devices in patients who undergo interbody fusion surgery. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with degenerative conditions in the thoracic and/or lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled into the study, subjects will undergo interbody fusion surgery using one of the NuVasive interbody implant groups based on the surgeon's standard of care. At least 1050 subjects (a minimum of 75 patients in each implant group) will be enrolled and will be followed for 24 months after the surgery.

Conditions

• Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Degenerative Scoliosis
• Spinal Stenosis
• Sagittal Deformity

Timeline

• Start date: 2020-10-01
• Primary completion: 2025-12-31
• Completion: 2026-07-01
• First posted: 2020-06-05
• Last updated: 2025-12-22

Locations

16 sites across 1 country: United States