## Protocol Section
### Identification Module
**NCT ID:** NCT06415136

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

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

#### Organization Study ID Info
**ID:** SeaSpine-001
#### Organization
**Class:** NETWORK
**Full Name:** Research Source
### Status Module
#### Completion Date
**Date:** 2027-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-05

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NETWORK

**Name:** Research Source

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Degenerative Disc Disease

- Disc Herniation

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All enrolled patients will receive the SeaSpine Shoreline device.

**Intervention Names:**

- Device: SeaSpine Shoreline

**Label:** SeaSpine Shoreline

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SeaSpine Shoreline

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

**Name:** SeaSpine Shoreline

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Motion, bridging on radiograph, and bridging bone on CT scan

**Measure:** Cervical fusion assessed via CT scan

**Time Frame:** 12 months post surgery

**Description:** 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.

**Measure:** Clinical outcome via neck visual analog scale (VAS)

**Time Frame:** 12 months post surgery

**Description:** 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.

**Measure:** Clinical outcome via neck disability index (NDI)

**Time Frame:** 12 months post surgery

**Description:** 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.

**Measure:** Clinical outcome via Dysphagia score

**Time Frame:** 12 months post surgery

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Southfield

**Country:** United States

**Facility:** Michigan Orthopaedic Surgeons

**State:** Michigan

**Zip:** 48033

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006547

- Term: Hernia

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M9625

- Name: Hernia

- Relevance: LOW

- As Found: Unknown

- ID: M10439

- Name: Intervertebral Disc Displacement

- Relevance: HIGH

- As Found: Disc Herniation

- ID: M28405

- Name: Intervertebral Disc Degeneration

- Relevance: HIGH

- As Found: Degenerative Disc Disease

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007405

- Term: Intervertebral Disc Displacement

- ID: D000055959

- Term: Intervertebral Disc Degeneration

### Misc Info Module

- Version Holder: 2024-05-31
