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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cervical Disc Disease
• Intervention / Treatment: Device: Elevation Spine Saber-C System

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Strenge Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Research Source

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Elevation Spine Reg-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No