Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating

Launched by RESEARCH SOURCE · May 10, 2024

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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