Novel carbon fiber pedicle screw system for the treatment of lumbar degenerative disc disease: Results from a prospective, multicenter, FDA investigational device exemption study.

ABSTRACT:

Background

Standard titanium pedicle screw systems are widely used in spinal fusion but produce imaging artifacts and may have limitations in fatigue resistance. CarboClear carbon fiber-reinforced PEEK (CFR-PEEK) implants offer improved radiolucency and fatigue properties, and negligible artifacts in MRI and CT scans. The purpose of this study was to evaluate the safety and effectiveness of CarboClear CFR-PEEK pedicle screw system for patients with degenerative disc disease (DDD) undergoing 1 level lumbar spinal fusion.

Methods

A prospective, multicenter, FDA-regulated Investigational Device Exemption (IDE) clinical trial, including 55 patients with DDD at 1 level (L2 to S1). Patients received the CarboClear System and a PEEK interbody fusion device. They were evaluated preo

SUBMITTER: Miller SD 

PROVIDER: S-EPMC12861189 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature