Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SeaSpine Shoreline.
- Who it may be relevant to
- Registry conditions: Degenerative Disc Disease, Disc Herniation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device SeaSpine Shoreline
The SeaSpine Shoreline device is a minimally invasive cervical plate/cage system.
Primary outcome measures
- Cervical fusion assessed via CT scan [Time frame: 12 months post surgery]
- Clinical outcome via neck visual analog scale (VAS) [Time frame: 12 months post surgery]
- Clinical outcome via neck disability index (NDI) [Time frame: 12 months post surgery]
- Clinical outcome via Dysphagia score [Time frame: 12 months post surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Michigan Orthopaedic Surgeons — Southfield
Identifiers
NCT: NCT06415136 · SeaSpine-001