A Clinical Registry to Track the Real World Use of the Saber-C® Cervical Fusion Device When Used for the Treatment of
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Cervical spinal fusion status assessed via X-rays and CT scans
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
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.
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.
Secondary Outcomes
No secondary outcomes reported