New artificial disc for neck pain under Real-World scrutiny
NCT ID NCT05305430
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is collecting real-world data on the Synergy Disc, an artificial disc implant for people with degenerative cervical disc disease. Researchers will follow 200 patients who have already received or will receive the implant, measuring pain and disability improvements over 12 months. The goal is to see if the device safely reduces neck and arm pain and improves function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Synergy Cervical Disc System (artificial disc implant)
- What this could lead to
- If successful, this could confirm that the Synergy Disc is a safe and effective option for treating neck and arm pain from cervical disc degeneration.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less definitive. Risks include device failure, nerve damage, or need for additional surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Both retrospective and prospective study subjects that have cervical degenerative disc disease requiring treatment with the Synergy Spine Solutions Synergy Disc. Prospective study cohort: All patients for whom it has been decided that the Synergy Spine Solutions Synergy Disc will be implanted at participating investigative centers and give informed consent to participate in the prospective segment of this protocol. Retrospective study cohort: Patients who have previously had a Synergy Spine Solutions Synergy Disc implanted. If required by local regulations, informed consent will be sought and received from the participating patient prior to data collection from the medical records per country-specific regulations.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Spine and Scoliosis Research Associates Australia Ltd
RECRUITINGWindsor, Victoria, Australia
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