Actively Recruiting
Real World Data Collection on the Synergy Disc
Led by Synergy Spine Solutions · Updated on 2026-01-09
50
Participants Needed
1
Research Sites
446 weeks
Total Duration
On this page
Sponsors
S
Synergy Spine Solutions
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Real World Data Collection on the Synergy Disc
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or older at the time of surgery
- Had or decided to have the Synergy Disc implanted
- Skeletally mature patients needing disc reconstruction from C3 to C7 after single or multiple level discectomy
- Intractable radiculopathy and/or myelopathy with symptomatic nerve root and/or spinal cord compression
- Compression caused by herniated disc and/or osteophyte formation confirmed by patient history and imaging (CT, MRI, x-rays)
- Failed at least 6 weeks of conservative treatment
- Provided written informed consent
You will not qualify if you...
- Moderate to advanced spondylosis
- Diagnosis of osteoporosis
- Active systemic infection or infection at the surgical site
- Pregnancy
- Marked cervical instability seen on radiographs
- Cervical spine conditions other than symptomatic cervical disc disease requiring surgery at the involved level
- Severe facet joint pathology at involved vertebral bodies
- Previous diagnosis of osteopenia or osteomalacia
- More than one immobile vertebral level between C1 and T1 for any cause
- Morbid obesity
- Vulnerable persons including pregnant patients, emergency cases, children, prisoners, and individuals without mental capacity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mater Misericordiae University Hospital
Dublin, Ireland
Actively Recruiting
Research Team
R
Robyn Capobianco, PhD
CONTACT
S
Stacy Gardner
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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