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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-04

Study Completion Date

2028-01-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cervical Disc Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Saber-C

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

Elevation Spine Saber-C System

Intervention Type DEVICE

Device: Elevation Spine Saber-C System Elevation Spine Saber-C System will be fixated between C2 through T1 according to surgeon standard of care at clinical practices through the United States.

Interventions

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Elevation Spine Saber-C System

Device: Elevation Spine Saber-C System Elevation Spine Saber-C System will be fixated between C2 through T1 according to surgeon standard of care at clinical practices through the United States.

Intervention Type DEVICE