NCT04689854

Cervical 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 Cervical Spine

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: NuVasive · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).

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 of the cervical spine. 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 cervical 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 150 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
• Cervical Spinal Instability

Timeline

• Start date: 2020-07-07
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2020-12-30
• Last updated: 2025-12-22

Locations

7 sites across 1 country: United States