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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06240221
Other study ID # Elevation Spine Reg-02
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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