RecruitingNot Applicable

Real World Data Collection on the Synergy Cervical Disc

Australia200 participantsStarted 2022-05-01

Plain-language summary

This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with degenerative cervical disc disease.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Over the age of 21 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, as applicable.

Exclusion criteria

. Moderate to advanced spondylosis
. Diagnosis of osteoporosis
. Active systemic infection or infection at the operative site

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neck Disability Index

Timeframe: 12 months

Device Related or Device Procedure Related Adverse Events

Timeframe: 12 months

Trial details

NCT IDNCT05305430

SponsorSynergy Spine Solutions

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-12

Contact for this trial

Robyn Capobianco, PhD

+1-647-692-3493 robync@synergyspinesolutions.com

View on ClinicalTrials.gov More Cervical Disc Degeneration trials