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

• Conditions: Degenerative Disc Disease; Disc Herniation
• Interventions: Device: SeaSpine Shoreline

• Registration Number: NCT06415136
• Lead Sponsor: Research Source

Brief Summary

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 Timeline

• Study Start: 2023-05-05
• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-15
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SeaSpine Shoreline	SeaSpine Shoreline	All enrolled patients will receive the SeaSpine Shoreline device.

Primary Outcome Measures

Name	Time	Method
Clinical outcome via neck disability index (NDI)	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.
Cervical fusion assessed via CT scan	12 months post surgery	Motion, bridging on radiograph, and bridging bone on CT scan
Clinical outcome via Dysphagia score	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.
Clinical outcome via neck visual analog scale (VAS)	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.

Trial Locations

Locations (1)

Michigan Orthopaedic Surgeons; 🇺🇸 Southfield, Michigan, United States