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

N/AEnrolling By InvitationNCT06415136

Research Source40 enrolled

Overview

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

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

Conditions

Degenerative Disc Disease Disc Herniation

Interventions

SeaSpine ShorelineDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Michigan Orthopaedic Surgeons

Southfield, Michigan, United States

Outcomes

Primary Outcomes

Cervical fusion assessed via CT scan

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

Time frame: 12 months post surgery

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months post surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.