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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06415136
• Other study ID #: SeaSpine-001
• Status: Enrolling by invitation
• Start date: May 5, 2023
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Research Source
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: May 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Disc Herniation
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement

Intervention

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

Locations

Country	Name	City	State
United States	Michigan Orthopaedic Surgeons	Southfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Research Source

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical fusion assessed via CT scan	Motion, bridging on radiograph, and bridging bone on CT scan	12 months post surgery
Primary	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
Primary	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
Primary	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