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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT06415136

SponsorResearch Source

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2027-05

View on ClinicalTrials.gov More Degenerative Disc Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

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

What they're measuring

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