Collecting real-world data on the Synergy cervical disc system
A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Synergy Spine Solutions Industry-sponsored |
| Locations | 1 site (Dublin) |
| Trial ID | NCT06383949 on ClinicalTrials.gov |
What this trial studies
This observational study collects real-world data on the safety and effectiveness of the Synergy cervical disc system in patients with cervical degenerative disc disease. It includes both prospective and retrospective cohorts, focusing on patients who have undergone or will undergo surgery involving the Synergy Disc. The study aims to document outcomes related to radiculopathy and myelopathy, assessing the impact of the disc replacement on patient symptoms and quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with symptomatic cervical degenerative disc disease who are scheduled for or have undergone surgery involving the Synergy Disc.
Not a fit: Patients with moderate to advanced spondylosis, osteoporosis, or marked cervical instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the Synergy cervical disc system, potentially improving treatment options for patients with cervical degenerative disc disease.
How similar studies have performed: Other studies on cervical disc replacement have shown promising results, suggesting that this approach may be effective, although the specific Synergy Disc system's outcomes are less established.
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: 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
Dublin
- Mater Misericordiae University Hospital — Dublin, Ireland (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.