Cervical Degenerative Disc DiseaseNCT04469231
The Synergy Disc To Anterior Cervical Discectomy and Fusion
A study testing Anterior Cervical Discectomy & Fusion in people with Cervical Degenerative Disc Disease, run by Synergy Spine Solutions at 20 sites in United States.
Trial summary
A multicenter, prospective, non-randomized, historically controlled study. Demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at only one level from C3 to C7 that… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Degenerative Disc Disease
- What is being tested?
- Anterior Cervical Discectomy & Fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 20 sitesUnited States
- Study dates
- 30 Oct 2020to 1 Jan 2026
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 70 years;
- Diagnosis of radiculopathy or myelopathy of the cervical spine, with either radiculopathy symptoms - pain, paresthesia, or paralysis in a specific nerve root distribution C4, C5, C6, or C7, including at least one of the following: arm/shoulder pain (at least 30 mm on 100 mm VAS scale); decreased muscle strength of at least one level on the 0-5 scale described below; abnormal sensation, including hyperesthesia or hypoesthesia; and/or abnormal reflexes; or myelopathy symptoms including positive Romberg evaluation, abnormal heel/toe walk, pathologic hyperreflexia or clonus in lower extremity, positive Babinski, or positive Hoffman's;
- Symptomatic at only one level from C3-C4 to C6-C7;
- Radiographically determined pathology at level to be treated correlating to primary symptoms, including at least one of the following:
- Decreased disc height compared to adjacent levels on radiographic film, CT, or MRI
- Degenerative spondylosis on CT or MRI
Show all 12Show fewer
- Disc herniation on CT or MRI.
- Neck Disability Index (NDI) score ≥ 30/100;
- Unresponsive to non-operative treatment for six weeks, or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of conservative treatment;
- Appropriate for treatment using an anterior surgical approach, including having no more than one previous anterior surgical approach to the cervical spine;
- Ability and willingness to comply with follow-up regimen; and
- Written informed consent given by subject or subject's legally authorized representative.
Who cannot join
- Infection at the site of surgery;
- History of, or anticipated treatment for, active systemic infection, including HIV infection or hepatitis C;
- Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy (greater than 6 months prior to scheduled surgical treatment), which includes removal of disc material necessary to perform a nerve root decompression, with less than one-third facetectomy at any level, or (2) a successful single-level anterior cervical fusion (greater than 6 months prior to scheduled surgical treatment);
- More than one immobile vertebral level between C1-T1 from any cause, including but not limited to congenital abnormalities, osteoarthritic "spontaneous" fusions, and prior cervical spinal fusions;
- Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentous cervical spine injury;
- Axial neck pain in the absence of other symptoms of radiculopathy or myelopathy justifying the need for surgical intervention;
Show all 35Show fewer
- Radiographic confirmation of severe facet joint disease or degeneration.
- Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation) for females or MORES (Male Osteoporosis Risk Estimation Score), will be used to screen patients to determine those patients who require a Hip DXA, a bone mineral density measurement. A SCORE or MORES ≥ 6 requires a DXA. If DXA is required, exclusion will be defined as a DXA bone density measured T score ≤ -2.5 (The World Health Organization definition of osteoporosis). DXA scans within the last 6 months prior to surgical treatment may be used;
- Paget's disease, osteomalacia, or any other metabolic bone disease (excluding osteoporosis which is addressed above);
- Severe diabetes mellitus requiring daily insulin management;
- Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
- Tumor as source of symptoms;
- Symptomatic DDD or significant cervical spondylosis at two or more levels;
- Marked cervical instability on resting lateral or flexion/extension radiographs demonstrated by:
- Translation > 3.5 mm and/or
- 11° angular difference to that of either adjacent level;
- Known or suspected allergy to cobalt, chromium, molybdenum, titanium, or polyethylene;
- Severe myelopathy to the extent that the patient is wheelchair bound;
- Congenital canal stenosis resulting in a canal diameter of < 10 mm, as measured by CT or MRI;
- Kyphotic segmental angulation of greater than 11 degrees at treatment or adjacent levels;
- Arachnoiditis;
- Pregnant (verified in patients of childbearing potential by a negative urine pregnancy test when pre-admission testing is obtained), or interested in becoming pregnant during the duration of the study;
- Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis);
- Congenital bony and/or spinal cord abnormalities that affect spinal stability;
- Spinal axis disease (thoracic or lumbar) to the extent that surgical consideration is likely anticipated within 6 months after the cervical procedure;
- Other degenerative joint disease (e.g. shoulder, hip, knee) to the extent that surgical consideration is likely anticipated within 6 months after the cervical procedure;
- Diseases or conditions that would preclude accurate clinical evaluation (e.g. neuromuscular disorders such as diffuse idiopathic skeletal hyperostosis (DISH));
- Medications that could interfere with fusion or other bone/soft tissue healing (e.g. anticipated continued use of systemic steroid medication postoperatively);
- Currently experiencing acute episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin;
- Current or recent history of substance abuse (drug or alcohol) per site PI's determination;
- Morbid obesity, defined as body mass index ("BMI") > 40;
- Currently using, or planning to use, bone growth stimulators in the cervical spine;
- Use of any other investigational drug or medical device within the last 30 days prior to surgery;
- Currently a prisoner;
- Currently pursuing personal litigation (defined as litigation that will likely influence the patient's ability or willingness to accurately report their treatment outcomes) related to the neck or cervical spine injury; however, involvement in worker's compensation related litigation is not a required exclusion.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Anschutz Medical Center
Aurora, Colorado, 80045
Central Texas Brain & Spine
Austin, Texas, 78705
Austin Neurosurgeons
Austin, Texas, 78746
Todd H. Lanman, M.D.
Beverly Hills, California, 90210
Indiana Spine Group
Carmel, Indiana, 46032
Center for Sports Medicine and Orthopaedic Surgery (CSMO)
Chattanooga, Tennessee, 37404
Exiamia EquiHealth
Durham, North Carolina, 27704
Upstate Medical University
East Syracuse, New York, 13057
Hospital for Special Surgery
New York, New York, 10021
Orthopedic Specialty Institute
Orange, California, 92868
Barrow Brain and Spine
Phoenix, Arizona, 85013
Summit Spine
Portland, Oregon, 97225
Atlantic Brain & Spine
Reston, Virginia, 20190
Texas Spine Care Center
San Antonio, Texas, 78231
Institute of Neuro Innovation
Santa Monica, California, 90404
Kennedy White Orthopaedic Center
Sarasota, Florida, 34232
HonorHealth Research Institute/Barrow Brain and Spine
Scottsdale, Arizona, 85251
Michigan Orthopedic Surgeons (2)
Southfield, Michigan, 48033
Michigan Orthopedic Surgeons
Southfield, Michigan, 48033
The Disc Replacement Center
West Jordan, Utah, 84088
About this study
Official title: A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD).
A multicenter, prospective, non-randomized, historically controlled study. Demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at only one level from C3 to C7 that are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, 3, 6, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. The primary analysis will occur at 24 months.
Read the detailed description
The proposed investigation is a prospective, non-randomized, multi-center, historically controlled comparison of the Synergy Disc to the control of conventional anterior cervical discectomy and fusion (ACDF) surgery in patients with cervical DDD. A total of 175 patients will be enrolled to the investigational group. The investigational group results will be compared to a historical control data from the ACDF control group, which utilized an identical study design. A statistically rigorous observational study design using propensity score (PS) subclassification will be used to demonstrate covariate balance and enhance the quality of inferences regarding effectiveness and safety relative to ACDF control. After investigational device enrollment is complete, but before most investigational device subjects have reached their 24-month endpoint, a data set containing only baseline covariates of prospectively enrolled investigational device patients and historical ACDF control patients will be constructed. The propensity score methods detailed below will be implemented by an outcomes-blinded statistician. A Propensity Score Memo summarizing the proposed observational design will be developed and submitted for review by stakeholders including FDA. The outcomes-blinded statistician will remain blinded until after consensus is achieved that the design is acceptable. This will allow for additional outcomes-blinded PS modeling if required. The objective of this clinical trial is to demonstrate the Synergy Disc is at least as safe and effective as conventional ACDF to treat cervical DDD in subjects who are symptomatic at only one level from C3 to C7 that are unresponsive to conservative management.
- Conditions
- Cervical Degenerative Disc Disease
- Being tested
- Anterior Cervical Discectomy & Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cervical Discectomy & FusionDevice
Also called ACDF
ACDF
| Study group | Role | What they receive |
|---|---|---|
| Synergy Disc | Experimental | The Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after anterior discectomy to provide restoration of motion to the functional spinal unit. The Synergy Disc is designed to restoring kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a single level discectomy for intractable radiculopathy and/or myelopathy. Receives: Device: Anterior Cervical Discectomy & Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
NDI
≥ 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline
Measured: 24 Month
Neurological Assessment
Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline
Measured: 24 Month
SSI
No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level
Measured: 24 Month
Device Related AE
Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event as adjudicated by the CEC.
Measured: 24 Month
Secondary outcomes (5)
SF-3
Health Survey (SF-36) at baseline and at each follow-up time-point
Measured: 6 Week, 3, 6, 12, and 24 Month
VAS
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. Please note, this assessment will include a "Worst" to pool together the left or right arm/shoulder scores with the higher baseline score. VAS Hoarseness on a 100mm scale.
Measured: 6 Week, 3, 6, 12, and 24 Month
Patient Satisfaction
Patient Satisfaction Questionnaire
Measured: 6 Week, 3, 6, 12, and 24 Month
BZ Score
Bazaz Dysphagia Score at 24 months compared to baseline
Measured: 6 Week, 3, 6, 12, and 24 Month
Odom's Criteria
Results at 24 months for the investigational Synergy Disc and at 24 months for the control ACDF will also be categorized by the physician according to Odom's Criteria.
Measured: 6 Week, 3, 6, 12, and 24 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start30 Oct 2020
- Primary completion19 Jun 2025
- Study completion1 Jan 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A multicenter, prospective, non-randomized, historically controlled study.
- Masking
- None (open label)
- Enrolment
- 175 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
- NCT04469231
- Sponsor's protocol ID
- 110-00001
- Status last verified
- Nov 2025
- First submitted
- 7 Jul 2020
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Historically Controlled Pivotal Trial Comparing The Safety And Effectiveness Of The Synergy Disc To Anterior Cervical Discectomy And Fusion In Patients With One-Level Symptomatic Cervical Degenerative Disc Disease (DDD).
- ClinicalTrials.gov ID
- NCT04469231
- Acronym / sponsor ID
- 110-00001
- Conditions
- Cervical Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Synergy Spine SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 13 Jul 2020 (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.
A multicenter, prospective, non-randomized, historically controlled study. Demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical degenerative disc disease (DDD) in subjects who are symptomatic at only one level from C3 to C7 that are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, 3, 6, 12, and 24 months after surgery. Follow-up will continue annually until the last patient reaches 24-month follow-up. The primary analysis will occur at 24 months.
Detailed description
The proposed investigation is a prospective, non-randomized, multi-center, historically controlled comparison of the Synergy Disc to the control of conventional anterior cervical discectomy and fusion (ACDF) surgery in patients with cervical DDD. A total of 175 patients will be enrolled to the investigational group. The investigational group results will be compared to a historical control data from the ACDF control group, which utilized an identical study design. A statistically rigorous observational study design using propensity score (PS) subclassification will be used to demonstrate covariate balance and enhance the quality of inferences regarding effectiveness and safety relative to ACDF control. After investigational device enrollment is complete, but before most investigational device subjects have reached their 24-month endpoint, a data set containing only baseline covariates of prospectively enrolled investigational device patients and historical ACDF control patients will be constructed. The propensity score methods detailed below will be implemented by an outcomes-blinded statistician. A Propensity Score Memo summarizing the proposed observational design will be developed and submitted for review by stakeholders including FDA. The outcomes-blinded statistician will remain blinded until after consensus is achieved that the design is acceptable. This will allow for additional outcomes-blinded PS modeling if required. The objective of this clinical trial is to demonstrate the Synergy Disc is at least as safe and effective as conventional ACDF to treat cervical DDD in subjects who are symptomatic at only one level from C3 to C7 that are unresponsive to conservative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A multicenter, prospective, non-randomized, historically controlled study.
| Arm | Type | Receives |
|---|---|---|
| Synergy Disc | Experimental | Device: Anterior Cervical Discectomy & FusionThe Synergy Disc is a cervical disc prosthesis that can be inserted between C3-C7 in skeletally mature patients after anterior discectomy to provide restoration of motion to the functional spinal unit. The Synergy Disc is designed to restoring kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a single level discectomy for intractable radiculopathy and/or myelopathy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 70 years;
- Diagnosis of radiculopathy or myelopathy of the cervical spine, with either radiculopathy symptoms - pain, paresthesia, or paralysis in a specific nerve root distribution C4, C5, C6, or C7, including at least one of the following: arm/shoulder pain (at least 30 mm on 100 mm VAS scale); decreased muscle strength of at least one level on the 0-5 scale described below; abnormal sensation, including hyperesthesia or hypoesthesia; and/or abnormal reflexes; or myelopathy symptoms including positive Romberg evaluation, abnormal heel/toe walk, pathologic hyperreflexia or clonus in lower extremity, positive Babinski, or positive Hoffman's;
- Symptomatic at only one level from C3-C4 to C6-C7;
- Radiographically determined pathology at level to be treated correlating to primary symptoms, including at least one of the following:
- Neck Disability Index (NDI) score ≥ 30/100;
Key exclusion criteria (35 listed)
- Infection at the site of surgery;
- History of, or anticipated treatment for, active systemic infection, including HIV infection or hepatitis C;
- Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomy (greater than 6 months prior to scheduled surgical treatment), which includes removal of disc material necessary to perform a nerve root decompression, with less than one-third facetectomy at any level, or (2) a successful single-level anterior cervical fusion (greater than 6 months prior to scheduled surgical treatment);
- More than one immobile vertebral level between C1-T1 from any cause, including but not limited to congenital abnormalities, osteoarthritic "spontaneous" fusions, and prior cervical spinal fusions;
- Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentous cervical spine injury;
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 |
|---|---|---|
| Anterior Cervical Discectomy & FusionAlso: ACDFACDF | Device | Synergy Disc |
Primary outcome
NDI
Time frame: 24 Month
≥ 15-point improvement in NDI Score (out of 100) in subjects at 24 months compared with baseline
Neurological Assessment
Time frame: 24 Month
Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline
SSI
Time frame: 24 Month
No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level
Device Related AE
Time frame: 24 Month
Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event as adjudicated by the CEC.
5 secondary outcomes
SF-3
Time frame: 6 Week, 3, 6, 12, and 24 Month
VAS
Time frame: 6 Week, 3, 6, 12, and 24 Month
Patient Satisfaction
Time frame: 6 Week, 3, 6, 12, and 24 Month
BZ Score
Time frame: 6 Week, 3, 6, 12, and 24 Month
Odom's Criteria
Time frame: 6 Week, 3, 6, 12, and 24 Month
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 19 Nov 2025.
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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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Cervical Discectomy & Fusion in people with Cervical Degenerative Disc Disease, run by Synergy Spine Solutions at 20 sites in United States.
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 12 inclusion and 35 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. 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?
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?
NDI (time frame: 24 Month). The study lists 4 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 19 Nov 2025.