Cervical Disc DegenerationNCT05305430
Real World Data Collection on the Synergy Cervical Disc
An observational study of Cervical Disc Degeneration, run by Synergy Spine Solutions at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cervical Disc Degeneration
- What is being tested?
- Synergy Cervical Disc System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 1 May 2022to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
- Currently a prisoner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christine Nimalasiri contact
Australia1 site, 1 recruiting
- Recruiting
Spine and Scoliosis Research Associates Australia Ltd
Windsor, Victoria
Sophie Cahir, sophie.monk@spineandscoliosis.comom
Aaron Buckland, MD
About this study
Official title: A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc
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.
- Conditions
- Cervical Disc Degeneration
- Being tested
- Synergy Cervical Disc System
- Keywords
- degenerative disc, cervical, radiculopathy, myelopathy, motion preservation
- Medical subject headings
- Radiculopathy, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synergy Cervical Disc SystemDevice
Also called Synergy Disc
motion preservation disc
| Study group | Role | What they receive |
|---|---|---|
| Prospective | 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. Receives: Device: Synergy Cervical Disc System | |
| Retrospective | 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. Receives: Device: Synergy Cervical Disc System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline
Measured: 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
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 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
Measured: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Nurick's Criteria
disease status characterized by physician at each visit
Measured: 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
Measured: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Neurologic Function
maintenance or improvement in neurologic status compared to baseline
Measured: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 May 2022
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synergy Spine Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pacific Clinical Research Group
- Responsible party
- Sponsor
- Investigators
- Robyn Capobianco, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305430
- Sponsor's protocol ID
- CP 21-001
- Status last verified
- May 2026
- First submitted
- 22 Mar 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc
- ClinicalTrials.gov ID
- NCT05305430
- Acronym / sponsor ID
- CP 21-001
- Conditions
- Cervical Disc Degeneration
- Keywords
- degenerative disc, cervical, radiculopathy, myelopathy, motion preservation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Synergy Spine SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Pacific Clinical Research Group
- Study start
- 1 May 2022 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Device: Synergy Cervical Disc SystemAll 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. |
| Retrospective | – | Device: Synergy Cervical Disc SystemPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synergy Cervical Disc SystemAlso: Synergy Discmotion preservation disc | Device | Prospective, Retrospective |
Primary outcome
Neck Disability Index
Time frame: 12 months
>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline
Device Related or Device Procedure Related Adverse Events
Time frame: 12 months
Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event
5 secondary outcomes
Visual Analog (VAS) pain
Time frame: pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively
Patient Satisfaction
Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Nurick's Criteria
Time frame: pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Odom's Criteria
Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Neurologic Function
Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Nimalasiri contact
Robyn Capobianco, PhD study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Degeneration, run by Synergy Spine Solutions at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robyn Capobianco, PhD (+1-647-692-3493, robync@synergyspinesolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.