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

NCT06415136 | Enrolling By Invitation FDA Device

• 1 other identifier: SeaSpine-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Degenerative Disc Disease; Disc Herniation

Outcome Measures

Primary Outcomes (4)

• Cervical fusion assessed via CT scan

  Motion, bridging on radiograph, and bridging bone on CT scan

  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.

  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.

  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.

  12 months post surgery

Study Arms (1)

SeaSpine Shoreline

All enrolled patients will receive the SeaSpine Shoreline device.

Device: SeaSpine Shoreline

Interventions

SeaSpine Shoreline DEVICE

The SeaSpine Shoreline device is a minimally invasive cervical plate/cage system.

SeaSpine Shoreline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Source: lead

Study Sites (1)

Michigan Orthopaedic Surgeons

Southfield, Michigan, 48033, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: May 5, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)