NCT05971329

Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Zetagen Therapeutics, Inc · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The goal of this pilot clinical trial is to test the safety and preliminary performance of the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain or loss of neurological function. Participants will be treated with ZetaFuse during surgical intervention to reduce pain and the loss of neurological function.

Detailed description

The indication under investigation is for use in the skeletally mature patients for fusion of one or two contiguous vertebral bodies in the cervical spine from C3-C7 following discectomy for intractable radiculopathy with or without neck pain, or myelopathy due to abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging:herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels.

Conditions

• Radiculopathy, Cervical
• Myelopathy Cervical
• Neurological Abnormality
• Disc Disease
• Disc Degeneration

Interventions

Type	Name	Description
DEVICE	Cervical Fusion (ZetaFuse™ Bone Graft)	Fusion of the C3-C7 cervical vertebral bodies

Timeline

• Start date: 2026-09-01
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2023-08-02
• Last updated: 2025-04-24

Locations

2 sites across 1 country: Australia