## Protocol Section
### Identification Module
**NCT ID:** NCT06413225

**Brief Title:** Post-Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc®

**Official Title:** A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®

#### Organization Study ID Info
**ID:** CP 21-001-UK01
#### Organization
**Class:** INDUSTRY
**Full Name:** Synergy Spine Solutions
### Status Module
#### Completion Date
**Date:** 2034-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2029-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-22
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** MCRA

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Synergy Spine Solutions

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.

### Conditions Module

**Conditions:**

- Cervical Degenerative Disc Disease

**Keywords:**

- radiculopathy

- myelopathy

- disc replacement

- motion preservation

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All patients for whom the decision has been made to have the Synergy Disc system implanted and give informed consent will be enrolled in this study, following country-specific requirements.

**Intervention Names:**

- Device: Synergy cervical disc system

**Label:** Prospective

#### Arm Group 2

**Description:** Patients who have previously received the Synergy Disc system in the last ten years are eligible for inclusion in the retrospective data collection; a waiver of consent, or an informed consent, for the retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations.

**Intervention Names:**

- Device: Synergy cervical disc system

**Label:** Retrospective

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Prospective

- Retrospective

**Description:** motion preservation disc

**Name:** Synergy cervical disc system

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Neck disability Index improvement of \>15 pts (out of 100) in subjects by 12 months post operative compared with baseline. A lower score is a better score.

**Measure:** Neck Disability Index (NDI)

**Time Frame:** 12 months

**Description:** Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event

**Measure:** device Related or Device Procedure Related Adverse Events

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Pain will evaluated by the Visual analog scale (VAS) (place a line from zero where there is no pain to 10 which is the worst pain imaginable), by NRS (circle a number from zero to ten where zero equals no pain and ten is worst imaginable) to or a verbal description that the doctor writes down, per the site's Standard of Care. A change of at least 20 mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up timepoint. Left and Right arm/shoulder pain as measured on a 100 mm VAS at baseline and at each follow up time-point.

**Measure:** Visual Analog Scale Neck and Arm Pain Measurement

**Time Frame:** pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively

**Description:** patient completed questionnaire on their satisfaction with the disc replacement surgery

**Measure:** Patient Satisfaction

**Time Frame:** 6 week, 3 month, 6 month, 12 month, annually post-operatively

**Description:** maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit)

**Measure:** Motor and Sensory Function in the Arm

**Time Frame:** pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively

**Description:** Disease status as characterized by physician at each time point

**Measure:** Nurick's Criteria

**Time Frame:** pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively

**Description:** surgical outcome characterized by physician at each post operative visit

**Measure:** Odom's criteria

**Time Frame:** 6 week, 3 month, 6 month, 12 month, annually post-operatively

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age 21 or above at the time of the surgery.
2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted
3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression:

   1. herniated disc and/or osteophyte formation
   2. Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.)
   3. Failed a minimum of 6 weeks conservative treatment
5. Written informed consent given by subject

Exclusion Criteria:

* Inclusion Criteria: All answers must be YES to be eligible for the study.

  1. Age 21 or above at the time of the surgery.
  2. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted
  3. Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy
  4. Intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression:

     1. herniated disc and/or osteophyte formation
     2. Symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (CT, MRI, x-rays, etc.)
     3. Failed a minimum of 6 weeks conservative treatment
  5. Written informed consent given by subject

Exclusion Criteria: All answers must be NO to be eligible for the study.

1. Moderate to advanced spondylosis
2. Diagnosis of osteoporosis
3. Active systemic infection or infection at the operative site
4. Pregnancy
5. Marked cervical instability on lateral, coronal, or flexion/extension radiographs
6. Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level
7. Severe pathology of the facet joints of the involved vertebral bodies
8. Previous diagnosis of osteopenia or osteomalacia
9. More than one immobile vertebral level between C1 and T1 from any cause
10. Morbid obesity
11. Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)

**Minimum Age:** 21 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** People over the age of 21 diagnosed with cervical degenerative disc disease and for whom the Synergy Disc device is an option (prospective cohort) or has already been implanted (retrospective cohort).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** janejacob@synergyspinesolutions.com

**Name:** Jane M Jacob

**Phone:** 5122895370

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** London

**Contacts:**

***Contact 1:***

- **Email:** gordan.grahovac@nhs.net

- **Name:** Gordan Grahovac, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Gordan Grahovac, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United Kingdom

**Facility:** Kings College Hospital

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

### Condition Browse Module - Browse Leaves

- ID: M14689

- Name: Radiculopathy

- Relevance: LOW

- As Found: Unknown

- ID: M28405

- Name: Intervertebral Disc Degeneration

- Relevance: HIGH

- As Found: Degenerative Disc Disease

- ID: M5134

- Name: Bone Marrow Diseases

- 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: D000055959

- Term: Intervertebral Disc Degeneration

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
