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

N/AEnrolling By InvitationNCT06240221

Research Source200 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Cervical Disc Disease

Interventions

Elevation Spine Saber-C SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Strenge Spine

Paducah, Kentucky, United States

Outcomes

Primary Outcomes

Cervical spinal fusion status assessed via X-rays and CT scans

Cervical spinal fusion status will be assessed via X-rays and CT scans at 1 year post-surgery

Time frame: 1 year

Clinical outcome via neck visual analog scale (VAS)

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.

Time frame: 1 year

Clinical outcome via neck disability index (NDI)

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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