Collecting real-world data on the Synergy Cervical Disc System
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Synergy Spine Solutions Industry-sponsored |
| Locations | 1 site (Windsor, Victoria) |
| Trial ID | NCT05305430 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with moderate to advanced spondylosis, osteoporosis, or active infections 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 leading to improved treatment options for patients with cervical disc degeneration.
How similar studies have performed: 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.
Eligibility criteria
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 this trial is running
Windsor, Victoria
- 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
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.