A Clinical Registry to Track the Real World Use of the Saber-C® Cervical Fusion Device

Research Source

Status: Invitation-only

Conditions: Cervical Disc Disease

Treatments: Device: Elevation Spine Saber-C System

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06240221

Elevation Spine Reg-02

Details and patient eligibility

About

The objective of this registry study is to collect radiographic and clinical outcome measures to determine the effectiveness of the Saber-C device.

Full description

The purpose of this Clinical Registry is to track the real world use the Saber-C cervical fusion device when used for the treatment of Cervical Degenerative Disc Disease from C-2 to T1 for Anterior Cervical Discectomy and Fusion (ACDF). The registry is intended to profile the use of the Saber-C cervical fusion device when used according to surgeon standard of care at clinical practices throughout the United States. The focus of the registry will be to track and better understand the safety, effectiveness and market value of the Saber-C cervical fusion device.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Planned treatment with the Saber-C implant
• Subject is willing and able to sign informed consent

Exclusion criteria

• Subject is pregnant
• Subject is a prisoner

Trial design

200 participants in 1 patient group

Saber-C

Description:

All enrolled patients will receive the Elevation Spine Saber-C System according to surgeon standard of care.

Treatment:

Device: Elevation Spine Saber-C System