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Enrolling by Invitation

NCT Number: NCT06240221

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

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

Enrolling by Invitation

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Key information

Conditions

Cervical Disc Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Strenge Spine

Paducah, Kentucky, 42003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elevation Spine Saber-C System

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.

Other names: Saber C, OVE, ODP, KWQ

Primary outcomes

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

    Time frame: 1 year

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

  2. Clinical outcome via neck visual analog scale (VAS)

    Time frame: 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.

  3. Clinical outcome via neck disability index (NDI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Research Source

Network

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 2, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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