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Enrolling by Invitation

NCT Number: NCT06415136

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

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

Enrolling by Invitation

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Disc Herniation Hernia Intervertebral Disc Degeneration Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Michigan Orthopaedic Surgeons

Southfield, Michigan, 48033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SeaSpine Shoreline

Device

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

Primary outcomes

  1. Cervical fusion assessed via CT scan

    Time frame: 12 months post surgery

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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Research Source

Network

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 16, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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