Actively Recruiting
Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®
Led by Synergy Spine Solutions · Updated on 2026-05-01
50
Participants Needed
2
Research Sites
506 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
Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 or above at the time of surgery
- Had or scheduled to have the Synergy Disc implanted
- Skeletally mature patients needing disc reconstruction from C3 to C7 after one or more discectomies
- Intractable radiculopathy and/or myelopathy causing symptomatic nerve root or spinal cord compression due to herniated disc or osteophyte formation
- Symptoms documented by patient history and imaging (CT, MRI, x-rays, etc.)
- 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 operative site
- Pregnancy
- Marked cervical instability seen on radiographs
- Cervical spine condition other than symptomatic cervical disc disease requiring surgery at the involved level
- Severe pathology of facet joints at involved vertebrae
- Previous diagnosis of osteopenia or osteomalacia
- More than one immobile vertebral level between C1 and T1 from any cause
- Morbid obesity
- Vulnerable persons including pregnant patients, emergency cases, children, prisoners, and people without mental capacity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Royal Orthopaedic Hospital
Birmingham, United Kingdom
Actively Recruiting
2
Kings College Hospital
London, United Kingdom
Actively Recruiting
Research Team
R
Robyn Capobianco, PhD
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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