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

NCT06240221 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: Elevation Spine Reg-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Disc Disease

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  1 year

Study Arms (1)

Saber-C

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

Device: Elevation Spine Saber-C System

Interventions

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.

Also known as: Saber C, OVE, ODP, KWQ

Saber-C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A patient who meets all inclusion criteria and none exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the Elevation Spine Saber-C System during the surgical procedure. If the surgeon decides intra-operatively not to utilize Saber-C, the patient will be considered a screen failure.

You may qualify if:

• years of age or older
• Planned treatment with the Saber-C implant
• Subject is willing and able to sign informed consent

You may not qualify if:

• Subject is pregnant
• Subject is a prisoner

Sponsors & Collaborators

• Research Source: lead

Study Sites (1)

Strenge Spine

Paducah, Kentucky, 42003, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 2, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)