Degenerative Disc DiseaseNCT06415136
Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating
An observational study of Degenerative Disc Disease and Disc Herniation, run by Research Source at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease, Disc Herniation
- What is being tested?
- SeaSpine Shoreline
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A patient who meets all inclusion criteria and none exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the SeaSpine Shoreline device during the surgical procedure. If the surgeon decides intra-operatively not to utilize the SeaSpine Shoreline device, the patient will be considered a screen failure.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Michigan Orthopaedic Surgeons
Southfield, Michigan, 48033
About this study
The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine.
Read the 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.
- Conditions
- Degenerative Disc Disease, Disc Herniation
- Being tested
- SeaSpine Shoreline
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeaSpine ShorelineDevice
The SeaSpine Shoreline device is a minimally invasive cervical plate/cage system.
| Study group | Role | What they receive |
|---|---|---|
| SeaSpine Shoreline | All enrolled patients will receive the SeaSpine Shoreline device. Receives: Device: SeaSpine Shoreline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical fusion assessed via CT scan
Motion, bridging on radiograph, and bridging bone on CT scan
Measured: 12 months post surgery
Clinical outcome via neck visual analog scale (VAS)
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.
Measured: 12 months post surgery
Clinical outcome via neck disability index (NDI)
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.
Measured: 12 months post surgery
Clinical outcome via Dysphagia score
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.
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start5 May 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Source
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415136
- Sponsor's protocol ID
- SeaSpine-001
- Status last verified
- Aug 2025
- First submitted
- 10 May 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating
- ClinicalTrials.gov ID
- NCT06415136
- Acronym / sponsor ID
- SeaSpine-001
- Conditions
- Degenerative Disc Disease, Disc Herniation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Research SourceResearch network
- Study start
- 5 May 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SeaSpine Shoreline | – | Device: SeaSpine ShorelineAll enrolled patients will receive the SeaSpine Shoreline device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A patient who meets all inclusion criteria and none exclusion criteria will be enrolled in the study. A patient is considered enrolled upon placement of the SeaSpine Shoreline device during the surgical procedure. If the surgeon decides intra-operatively not to utilize the SeaSpine Shoreline device, the patient will be considered a screen failure.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeaSpine ShorelineThe SeaSpine Shoreline device is a minimally invasive cervical plate/cage system. | Device | SeaSpine Shoreline |
Primary outcome
Cervical fusion assessed via CT scan
Time frame: 12 months post surgery
Motion, bridging on radiograph, and bridging bone on CT scan
Clinical outcome via neck visual analog scale (VAS)
Time frame: 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)
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Disc Herniation, run by Research Source at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical fusion assessed via CT scan (time frame: 12 months post surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.