NCT04689880

XLIF Decade Plate System Study

A Prospective, Multicenter Study Evaluating the Safety and Performance of the NuVasive® XLIF Decade™ Plate System for the Treatment of Patients With Pathologic Conditions of the Thoracic and/or Lumbar Spine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• 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 the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.

Detailed description

This study is a prospective, single-arm, multicenter study to evaluate the safety and performance of the XLIF Decade Plate in patients undergoing a thoracic and/or lumbar interbody fusion, at one or two levels, with supplemental fixation using a lateral plate. Consecutive patients at a given site who meet all eligibility requirements will be asked to consent to participate in the study. Eligible patients include those 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 in the study, subjects will undergo XLIF surgery with lateral plating using the Decade Plate. At least 75 subjects will be enrolled and will be followed for 24 months after surgery.

Conditions

• Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Degenerative Scoliosis

Timeline

• Start date: 2021-04-12
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2020-12-30
• Last updated: 2025-12-22

Locations

1 site across 1 country: United States