Collecting real-world data on the Synergy Cervical Disc System
Official title: A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc
Run by Synergy Spine Solutions · NCT05305430 · Data updated 2026-11-12
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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Synergy Spine Solutions Industry-sponsored |
| Locations | 1 site (Windsor, Victoria) |
| Status | Recruiting |
| Started | May 1, 2022 |
| Main results expected | December 2030 |
| Study ends | December 2032 |
| Registry record updated | May 8, 2026 |
| Trial ID | NCT05305430 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 21 years old who are experiencing intractable radiculopathy or myelopathy and are scheduled to receive the Synergy Cervical Disc implant.
✕Probably not a fit
Patients with moderate to advanced spondylosis, osteoporosis, or active infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to gather real-world data on the safety and effectiveness of the Synergy Cervical Disc System in patients suffering from cervical disc degeneration. It includes both prospective and retrospective cohorts, focusing on individuals who have undergone or will undergo surgery involving the Synergy Disc. The study will evaluate outcomes related to intractable radiculopathy and myelopathy, assessing the impact of the disc system on patient symptoms and quality of life.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the Synergy Cervical Disc System, potentially leading to improved treatment options for patients with cervical disc degeneration.
How similar studies have gone: While this study focuses on a specific device, similar observational studies have shown promise in evaluating real-world outcomes for spinal interventions, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Spine and Scoliosis Research Associates Australia Ltd
Windsor, Victoria, Australia Recruiting
Study contacts
- Study coordinator: Robyn Capobianco, PhD
- Email: robync@synergyspinesolutions.com
- Phone: +1-647-692-3493
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating the cost-effectiveness of cervical disc surgery techniques
This study is testing which of two surgery options for neck pain from disc problems is more cost-effective and beneficial for patients.
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Real-world performance of the Synergy cervical 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.
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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.
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.