A Clinical Registry to Track the Real World Use of the Saber-C® Cervical Fusion Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elevation Spine Saber-C System.
- Who it may be relevant to
- Registry conditions: Cervical Disc Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Registry to Track the Real World Use of the Saber-C® Cervical Fusion Device When Used for the Treatment of
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Cervical spinal fusion status assessed via X-rays and CT scans [Time frame: 1 year]
- Clinical outcome via neck visual analog scale (VAS) [Time frame: 1 year]
- Clinical outcome via neck disability index (NDI) [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Strenge Spine — Paducah
Identifiers
NCT: NCT06240221 · Elevation Spine Reg-02