Cervical Degenerative Disc DiseaseNCT06413225
Multi-Centre Post-Market Data Collection
An observational study of Cervical Degenerative Disc Disease, run by Synergy Spine Solutions at 2 sites in United Kingdom.
Trial summary
This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study 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 Degenerative Disc Disease
- What is being tested?
- Synergy cervical disc system
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 25 Sep 2024to 25 Sep 2034
- Phase
- Observational
- Are there results?
- None posted in the registry
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: People over the age of 21 diagnosed with cervical degenerative disc disease and for whom the Synergy Disc device is an option (prospective cohort) or has already been implanted (retrospective cohort).
Who may be able to join
- Age 21 or above 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
Who cannot join
- Inclusion Criteria: All answers must be YES to be eligible for the study.
- Age 21 or above 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
Show all 21Show fewer
- 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
- Exclusion Criteria: All answers must be NO to be eligible for the study.
- 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
- 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
- Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Orthopedic Hospital
Birmingham
Kings College Hospital
London
About this study
Official title: Multi-centre Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®
This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.
- Conditions
- Cervical Degenerative Disc Disease
- Being tested
- Synergy cervical disc system
- Keywords
- radiculopathy, myelopathy, disc replacement, 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
motion preservation disc
| Study group | Role | What they receive |
|---|---|---|
| Prospective | All patients for whom the decision has been made to have the Synergy Disc system implanted and give informed consent will be enrolled in this study, following country-specific requirements. Receives: Device: Synergy cervical disc system | |
| Retrospective | Patients who have previously received the Synergy Disc system in the last ten years are eligible for inclusion in the retrospective data collection; a waiver of consent, or an informed consent, for the retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations. 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 (NDI)
Neck disability Index improvement of >15 pts (out of 100) in subjects by 12 months post operative compared with baseline. A lower score is a better score.
Measured: 12 months
device Related or Device Procedure Related Adverse Events
Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event
Measured: 12 months
Secondary outcomes (5)
Visual Analog Scale Neck and Arm Pain Measurement
Pain will evaluated by the Visual analog scale (VAS) (place a line from zero where there is no pain to 10 which is the worst pain imaginable), by NRS (circle a number from zero to ten where zero equals no pain and ten is worst imaginable) to or a verbal description that the doctor writes down, per the site's Standard of Care. A change of at least 20 mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up timepoint. Left and Right arm/shoulder pain as measured on a 100 mm VAS at baseline and at each follow up time-point.
Measured: pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively
Patient Satisfaction
patient completed questionnaire on their satisfaction with the disc replacement surgery
Measured: 6 week, 3 month, 6 month, 12 month, annually post-operatively
Motor and Sensory Function in the Arm
maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit)
Measured: pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively
Nurick's Criteria
Disease status as characterized by physician at each time point
Measured: pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively
Odom's criteria
surgical outcome characterized by physician at each post operative visit
Measured: 6 week, 3 month, 6 month, 12 month, 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 posted14 May 2024
- Study start25 Sep 2024 (estimated)
- Primary completion25 Sep 2029 (estimated)
- Study completion25 Sep 2034 (estimated)
Why it stopped: Multiple sites in the UK, went to EC for multicenter approval after this record was written
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Degenerative Disc DiseaseStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synergy Spine Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413225
- Sponsor's protocol ID
- CP 21-001-UK01
- Status last verified
- Jun 2025
- First submitted
- 22 Apr 2024
- Last updated
- 17 Jun 2025
- Results posted
- 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 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®
- ClinicalTrials.gov ID
- NCT06413225
- Acronym / sponsor ID
- CP 21-001-UK01
- Conditions
- Cervical Degenerative Disc Disease
- Keywords
- radiculopathy, myelopathy, disc replacement, motion preservation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Multiple sites in the UK, went to EC for multicenter approval after this record was written
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Synergy Spine SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 25 Sep 2024 (estimated)
- Primary completion
- 25 Sep 2029 (estimated)
- Study completion
- 25 Sep 2034 (estimated)
- First posted
- 14 May 2024 (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 is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study 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 system implanted and give informed consent will be enrolled in this study, following country-specific requirements. |
| Retrospective | – | Device: Synergy cervical disc systemPatients who have previously received the Synergy Disc system in the last ten years are eligible for inclusion in the retrospective data collection; a waiver of consent, or an informed consent, for the retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People over the age of 21 diagnosed with cervical degenerative disc disease and for whom the Synergy Disc device is an option (prospective cohort) or has already been implanted (retrospective cohort).
Key inclusion criteria (8 listed)
- Age 21 or above 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:
- Written informed consent given by subject
Key exclusion criteria (21 listed)
- Inclusion Criteria: All answers must be YES to be eligible for the study.
- Exclusion Criteria: All answers must be NO to be eligible for the study.
- Moderate to advanced spondylosis
- Diagnosis of osteoporosis
- Active systemic infection or infection at the operative site
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 systemmotion preservation disc | Device | Prospective, Retrospective |
Primary outcome
Neck Disability Index (NDI)
Time frame: 12 months
Neck disability Index improvement of >15 pts (out of 100) in subjects by 12 months post operative compared with baseline. A lower score is a better score.
device Related or Device Procedure Related Adverse Events
Time frame: 12 months
Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event
5 secondary outcomes
Visual Analog Scale Neck and Arm Pain Measurement
Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively
Patient Satisfaction
Time frame: 6 week, 3 month, 6 month, 12 month, annually post-operatively
Motor and Sensory Function in the Arm
Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively
Nurick's Criteria
Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, annually post-operatively
Odom's criteria
Time frame: 6 week, 3 month, 6 month, 12 month, annually post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Degenerative Disc Disease, run by Synergy Spine Solutions at 2 sites in United Kingdom.
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 8 inclusion and 21 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: withdrawn, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (NDI) (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 17 Jun 2025.