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

Research Source

Status: Invitation-only

Conditions: Degenerative Disc Disease; Disc Herniation

Treatments: Device: SeaSpine Shoreline

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06415136

SeaSpine-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 1 patient group

SeaSpine Shoreline

Description:

All enrolled patients will receive the SeaSpine Shoreline device.

Treatment:

Device: SeaSpine Shoreline