Real-world performance of the Synergy cervical disc
Official title: A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®
Run by Synergy Spine Solutions · NCT06383962 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Synergy Spine Solutions Industry-sponsored |
| Locations | 2 sites (Birmingham and 1 other locations) |
| Status | Recruiting |
| Started | March 17, 2025 |
| Main results expected | December 2029 |
| Study ends | December 2034 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT06383962 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Collecting real-world data on the Synergy cervical disc system
This study is collecting information on how well the Synergy cervical disc system works and its safety for patients with neck disc problems who have had or will have surgery.
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Collecting real-world data on the Synergy Cervical Disc System
This study is trying to see how well the Synergy Cervical Disc System works and how safe it is for people with cervical disc problems who have had or will have surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.