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

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 preoperatively and postoperatively at 6 weeks, 3, 6, 12, and 24 months, and then annually until the last patient completed 24-month follow-up. Primary outcome measures included self-reporting Visual Analog Scale (VAS) pain scores and Oswestry Disability Index (ODI), radiographic fusion rate, and safety assessments. Secondary measures included self-reporting SF-12 Health Survey (SF-12) scores and patient satisfaction (VAS), and operative parameters. Results were compared to predefined literature control group.

RESULTS

At 24 months, 90.0% of the patients had clinically meaningful pain improvement (VAS ≥ 20), and 78.0% had ODI improvement ≥15 points. Rigorously defined fusion was achieved in 85.71% of the patients at 24 months and in 94.59% at 36 months. The neurological success rate was 93.33%. No serious device-related adverse events occurred. The 24-month index-level reoperation rate was 7.14%, including 1 implant removal case (1.79%). Compared to the literature control, CarboClear device demonstrated superior imaging clarity and at least equivalent clinical outcomes.

CONCLUSIONS

The CarboClear System is a safe and effective alternative to titanium pedicle screws for lumbar fusion, providing improved imaging compatibility and fatigue resistance.