Degenerative Disc Disease, Disc Herniation
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine.
Detailed description
This is a retrospective, prospective, post-market, observational, single-center, single surgeon study evaluating the use of the SeaSpine Shoreline device. Patients will be identified by the Investigator as needing, or already received the device during a cervical fusion surgery and meeting all the inclusion and none of the exclusion criteria.
Interventions
DEVICESeaSpine Shoreline
The SeaSpine Shoreline device is a minimally invasive cervical plate/cage system.
Sponsors
Research Source
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Appropriate patient, as determined by the Investigator, scheduled for an elective cervical spine fusion to treat adjacent level cervical disc herniation or degeneration resulting in cervical radiculopathy or myelopathy 2. At least 18 years of age 3. Failure of nonoperative care 4. Previous anterior cervical plating 5. Psychosocially, mentally and physically able to comply with this protocol including adhering to follow-up schedule and study requirements
Exclusion criteria
1. Pregnancy or anticipated to become pregnant during the course of the study 2. No previous cervical spine surgery 3. Non-instrumented cervical fusion 4. Cervical fusion with separate plate fixation 5. Unwilling or unable to sign consent 6. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol 7. Currently a prisoner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical fusion assessed via CT scan | 12 months post surgery | Motion, bridging on radiograph, and bridging bone on CT scan |
| Clinical outcome via neck visual analog scale (VAS) | 12 months post surgery | 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) | 12 months post surgery | 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. |
| Clinical outcome via Dysphagia score | 12 months post surgery | Standard of care patient reported dysphagia score will be used to evaluate patient inability or difficulty swallowing. On a scale of 0 to 4 with a score of 0 meaning no difficulty and 4 meaning severe problem. A low score means a better clinical outcome. A high score means a worse clinical outcome. |
Countries
United States
Outcome results
None listed