Real-world performance of the Synergy cervical disc
A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®
This observational program will collect real-world data to see how well and how safe the Synergy cervical disc is for adults with degenerative cervical disc disease who receive the implant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Synergy Spine Solutions Industry-sponsored |
| Locations | 2 sites (Birmingham and 1 other locations) |
| Trial ID | NCT06383962 on ClinicalTrials.gov |
What this trial studies
This is a real-world observational registry including both retrospective and prospective cohorts of adults treated with the Synergy cervical disc for degenerative disease from C3 to C7. The program captures clinical outcomes, imaging, and safety events after single- or multi-level disc replacement following discectomy, with scheduled baseline and follow-up data collection. Eligible patients are skeletally mature adults (≥21) with symptomatic radiculopathy or myelopathy who have failed at least six weeks of conservative care; key exclusions include moderate-to-advanced spondylosis, osteoporosis, active infection, and pregnancy. Data are collected at participating clinical centers to characterize device performance and complication rates in routine practice.
Who should consider this trial
Good fit: Adults aged 21 or older with symptomatic cervical degenerative disc disease at C3–C7 who have failed at least six weeks of conservative treatment and have had or are scheduled to receive the Synergy cervical disc after discectomy are ideal candidates.
Not a fit: Patients with moderate-to-advanced spondylosis, diagnosed osteoporosis, active systemic or operative-site infection, or pregnancy were excluded and are unlikely to benefit from this device in the context of this program.
Why it matters
Potential benefit: If successful, it could reassure patients and clinicians that the Synergy disc is safe and can relieve symptoms while preserving neck motion in routine clinical use.
How similar studies have performed: Cervical total disc replacement as a treatment class has shown favorable results versus fusion in prior trials, and this post-market collection aims to add real-world safety and effectiveness data for the Synergy device specifically.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age 21 or above at the time of the surgery. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy 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 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.) Failed a minimum of 6 weeks conservative treatment Written informed consent given by subject. Exclusion Criteria: Exclusion Criteria: All answers must be NO to be eligible for the study. Moderate to advanced spondylosis Diagnosis of osteoporosis Active systemic infection or infection at the operative site Pregnancy Marked cervical instability on lateral, coronal, or flexion/extension radiographs Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level Severe pathology of the facet joints of the involved vertebral bodies Previous diagnosis of osteopenia or osteomalacia More than one immobile vertebral level between C1 and T1 from any cause Morbid obesity Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)
Where this trial is running
Birmingham and 1 other locations
- Royal Orthopaedic Hospital — Birmingham, United Kingdom (Recruiting)
- Kings College Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Robyn Capobianco, PhD
- Email: rcapobianco@synergyspinesolutions.com
- Phone: (720) 787-9063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.