Real World Data Collection on the Synergy Cervical Disc

Cervical Disc Degeneration Clinical Trial

Official title:

A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305430
• Other study ID #: CP 21-001
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: March 2028

Study information

• Verified date: February 2024
• Source: Synergy Spine Solutions
• Contact: Jane M Jacob, PhD
• Phone: +1 512-289-5370
• Email: janejacob[@]synergyspinesolutions.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with degenerative cervical disc disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2028
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Over the age of 21 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: herniated disc and/or osteophyte formation

5. 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.)

6. Failed a minimum of 6 weeks conservative treatment

7. Written informed consent given by subject, as applicable.

Exclusion Criteria:

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. Currently a prisoner

Related Conditions & MeSH terms

• Cervical Disc Degeneration
• Intervertebral Disc Degeneration

Intervention

Device:
• Synergy Cervical Disc System
motion preservation disc

Locations

Country	Name	City	State
Australia	Greenslopes Private Hospital	Brisbane	Queensland
Australia	Dr. Greg Malham	Melbourne	Victoria
Australia	Spine and Scoliosis Research Associates Australia Ltd	Windsor	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Synergy Spine Solutions	Pacific Clinical Research Group

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index	>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline	12 months
Primary	Device Related or Device Procedure Related Adverse Events	Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event	12 months
Secondary	Visual Analog (VAS) pain	Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up time-point.	pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively
Secondary	Patient Satisfaction	patient completed questionnaire on satisfaction with disc replacement surgery	6 weeks, 3 months, 6 months, 12 months, annually post operatively
Secondary	Nurick's Criteria	disease status characterized by physician at each visit	pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Secondary	Odom's Criteria	surgical outcome characterized by physician at each post operative visit	6 weeks, 3 months, 6 months, 12 months, annually post operatively
Secondary	Neurologic Function	maintenance or improvement in neurologic status compared to baseline	6 weeks, 3 months, 6 months, 12 months, annually post operatively