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

Cervical Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06240221
• Other study ID #: Elevation Spine Reg-02
• Status: Enrolling by invitation
• Start date: April 4, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: April 2024
• Source: Research Source
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Strenge Spine	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Research Source

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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