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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Degenerative Disc Disease; Disc Herniation
• Intervention / Treatment: Device: SeaSpine Shoreline

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Southfield, Michigan, United States, 48033
      • Michigan Orthopaedic Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

1. 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
2. At least 18 years of age
3. Failure of nonoperative care
4. Previous anterior cervical plating
5. Psychosocially, mentally and physically able to comply with this protocol including adhering to follow-up schedule and study requirements

Exclusion Criteria:

1. Pregnancy or anticipated to become pregnant during the course of the study
2. No previous cervical spine surgery
3. Non-instrumented cervical fusion
4. Cervical fusion with separate plate fixation
5. Unwilling or unable to sign consent
6. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
7. Currently a prisoner

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SeaSpine Shoreline; All enrolled patients will receive the SeaSpine Shoreline device.	Device: SeaSpine Shoreline; The SeaSpine Shoreline device is a minimally invasive cervical plate/cage system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cervical fusion assessed via CT scan	Motion, bridging on radiograph, and bridging bone on CT scan	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

Collaborators and Investigators

• Sponsor: Research Source

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
• Other Study ID Numbers: SeaSpine-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No