An observational study in Cervical Disc Degeneration, sponsored by Synergy Spine Solutions. Recruiting at 1 site in Australia. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Synergy Spine Solutions · Observational
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.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 95 observational studies indexed under Radiculopathy.
Browse Radiculopathy studies →Synergy Spine Solutions is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients for whom the decision has been made to have the Synergy Disc implanted at participating investigative centers and give informed consent to participate in the prospective segment of this protocol, per country-specific requirements, will be enrolled in the prospective portion of this protocol.
Device: Synergy Cervical Disc System
Patients who have previously had a Synergy Spine Solutions Synergy Disc implanted will be eligible for inclusion in the retrospective data collection; a waiver of consent, or informed consent, for retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations as applicable.
Device: Synergy Cervical Disc System
motion preservation disc
Also known as: Synergy Disc
Neck Disability Index
\>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline
Time frame: 12 months
Device Related or Device Procedure Related Adverse Events
Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event
Time frame: 12 months
Visual Analog (VAS) pain
Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up time-point.
Time frame: pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively
Patient Satisfaction
patient completed questionnaire on satisfaction with disc replacement surgery
Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Nurick's Criteria
disease status characterized by physician at each visit
Time frame: pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Odom's Criteria
surgical outcome characterized by physician at each post operative visit
Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Neurologic Function
maintenance or improvement in neurologic status compared to baseline
Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Plan to share: No
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for Dec 2030, 103 months after the start.
Of 40 observational studies under Radiculopathy, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 95. This study's planned 103 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Synergy Spine Solutions