By InvitationNot Applicable

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

United States40 participantsStarted 2023-05-05

Plain-language summary

The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. At least 18 years of age
✓. Failure of nonoperative care
✓. Previous anterior cervical plating
✓. Psychosocially, mentally and physically able to comply with this protocol including adhering to follow-up schedule and study requirements

✕. Pregnancy or anticipated to become pregnant during the course of the study
✕. No previous cervical spine surgery
✕. Non-instrumented cervical fusion
✕. Cervical fusion with separate plate fixation
✕. Unwilling or unable to sign consent
✕. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
✕. Currently a prisoner

Cervical fusion assessed via CT scan

Timeframe: 12 months post surgery

Clinical outcome via neck visual analog scale (VAS)

Timeframe: 12 months post surgery

Clinical outcome via neck disability index (NDI)

Timeframe: 12 months post surgery

Clinical outcome via Dysphagia score

Timeframe: 12 months post surgery

NCT IDNCT06415136

SponsorResearch Source

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2027-05