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

• Conditions: Cervical Disc Disease
• Interventions: Device: Elevation Spine Saber-C System

• Registration Number: NCT06240221
• Lead Sponsor: Research Source

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-02-02
• Status Verified: 2024-04
• Study Start: 2024-04-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2026-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cervical spinal fusion status assessed via X-rays and CT scans	1 year	Cervical spinal fusion status will be assessed via X-rays and CT scans at 1 year post-surgery
Clinical outcome via neck visual analog scale (VAS)	1 year	Standard of care patient reported neck visual analog scale (VAS) will be used to evaluate patient pain. On a scale of 0 to 10 with a score of 0 being no pain and a score of 10 being worst pain. A low score means a better clinical outcome. A high score means a worse clinical outcome.
Clinical outcome via neck disability index (NDI)	1 year	Standard of care patient reported neck disability index (NDI) will be used to evaluate patient pain and quality of life. On a vertical scale of 0 to 5 with a score of 0 meaning neck pain (if any) does not interfere with life activities and 5 meaning neck pain strongly interferes with life activities. A low score means a better clinical outcome. A high score means a worse clinical outcome.

Trial Locations

Locations (1)

Strenge Spine; 🇺🇸 Paducah, Kentucky, United States