Cervical Degenerative Disc DiseaseNCT05740176
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
A study testing Anterior Cervical Discectomy and Fusion in people with Cervical Degenerative Disc Disease, run by Synergy Spine Solutions at 23 sites in United States.
Trial summary
A multicenter, prospective, non-randomized, historically controlled study. To 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 two levels from C3 to C7 are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Degenerative Disc Disease
- What is being tested?
- Anterior Cervical Discectomy and Fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 23 sitesUnited States
- Study dates
- 1 Jun 2023to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- Must be at least 18 years of age and be skeletally mature at the time of surgery
- Has a preoperative neck pain score ≥ 8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.
- Has cervical degenerative disc disease at two (2) adjacent cervical levels (from C3 - C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy, or both;
- Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history (e.g., neck pain with arm pain, functional deficit and/or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
- Neck Disability Index (NDI) score ≥ 30/100 (raw score of ≥ 15/50);
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- Has been unresponsive to non-operative treatment for at least six weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management; has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s);
- If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period;
- Is willing to comply with the study plan and sign the Patient Informed Consent Form
Who cannot join
- Subjects who meet any of the following criteria will be excluded from participation in this study:
- Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels;
- Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing:
- Sagittal plane translation > 3.5 mm, or
- Sagittal plane angulation > 20°;
- 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);
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- Has severe pathology of the facet joints of the involved vertebral bodies;
- Axial neck pain only (no radicular or myelopathy symptoms);
- Has been previously diagnosed with osteomalacia;
- Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation) for females or MORES for males (Male Osteoporosis Risk Estimation Score), will be used to screen patients to determine those patients who require a DXA of the hip, 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;
- Has presence of spinal metastases;
- Has overt or active bacterial infection, either local or systemic;
- Has insulin-dependent diabetes;
- Has chronic or acute renal failure or prior history of renal disease;
- Known titanium or UHMWPE allergy;
- Is mentally incompetent (if questionable, obtain psychiatric consult);
- Is a prisoner;
- Is pregnant ;
- Is currently an alcohol and/or drug abuser or currently undergoing treatment for alcohol and/or drug abuse;
- Is involved with current or pending litigation regarding a spinal condition;
- Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs;
- Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta);
- Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs;
- Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Austin Neurosurgeons
Austin, Texas, 78746
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, 70808
Todd Lanman, MD
Beverly Hills, California, 90210
Indiana Spine Group
Carmel, Indiana, 46032
Carolina NeuroSurgery and Spine Associates, PA
Charlotte, North Carolina, 28204
Brain and Spine Center of South Florida
Delray Beach, Florida, 33445
M3 Emerging Medical Research
Durham, North Carolina, 27704
INOVA Neurosurgery
Fairfax, Virginia, 20190
Orthopedics Northeast
Fort Wayne, Indiana, 46825
DFW Center for Spinal Disorders
Fort Worth, Texas, 76132
DOCS Health Management LLC
Los Angeles, California, 90048
Precision Spine and Orthopaedic Associates, PA
Overland Park, Kansas, 66211
Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374
Summit Spine
Portland, Oregon, 97225
Michigan Orthopedic Surgeons
Royal Oak, Michigan, 48073
Texas Spine Care Center
San Antonio, Texas, 78231
Institute of Neuro Innovation
Santa Monica, California, 91304
Kennedy-White Orthopaedic Center
Sarasota, Florida, 34232
HonorHealth
Scottsdale, Arizona, 85258
Louisiana Spine Institute
Shreveport, Louisiana, 71101
Steamboat Orthopaedic and Spine Institute
Steamboat Springs, Colorado, 80487
Oregon Spine Care
Tualatin, Oregon, 97062
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 Two-Level Symptomatic Cervical Degenerative Disc Disease (DDD)
A multicenter, prospective, non-randomized, historically controlled study. To 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 two levels from C3 to C7 are and are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, and 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
This is a research study comparing two ways of treating neck problems caused by degenerative disc disease (wear-and-tear damage to the discs that cushion the bones in the neck).
The study is comparing:
The Synergy Disc - an artificial disc device being studied in this trial, and Standard surgery (ACDF) - a widely used procedure called anterior cervical discectomy and fusion, which is the accepted current treatment.
Up to 200 people will receive the Synergy Disc as part of this study. Their results will be compared to results from people who had the standard ACDF surgery in the past, rather than assigning some people to get ACDF during this study (this is called a "historical control"). The study takes place at multiple medical centers.
Who this study is for:
People who are fully grown (skeletally mature) and have damage in two neighboring discs in the neck (located somewhere between the C3 and C7 vertebrae). To qualify, a person's symptoms must include:
Arm pain and/or nerve-related weakness or numbness (radiculopathy) that hasn't improved, and Neck pain or signs of spinal cord compression (myelopathy)
These symptoms must be caused by problems in the two affected disc levels, and must not have gotten better with non-surgical treatment (such as physical therapy, medication, or injections).
What the study will measure:
Whether the Synergy Disc is as safe and effective as standard ACDF surgery for people who need surgery to relieve pressure on the nerves or spinal cord at two neighboring disc levels in the neck.
- Conditions
- Cervical Degenerative Disc Disease
- Being tested
- Anterior Cervical Discectomy and Fusion
- Keywords
- degenerative disc disease, cervical, artificial disc replacement, motion preservation, motion preservation disc, cervical TDR
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Cervical Discectomy and FusionDevice
Also called ACDF
Anterior cervical discectomy is a surgical procedure that was developed to treat damaged cervical discs by relieving pressure on the nerve roots or on the spinal cord by removing the ruptured disc. The operation is performed by reaching the cervical spine through a small incision in the front of the neck. The soft tissues of the neck are then separated allowing for the disc to be removed. Anterior cervical discectomy has proven to be a safe and effective procedure for the treatment of degenerative disc disease. The anterior approach allows direct visualization of the entire interspace and wide decompression of the anterior aspect cervical spinal cord and nerve roots. It may be undertaken in cases of multilevel disease and interbody fusion may be performed if required
| 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 restore kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a two level discectomy for intractable radiculopathy and/or myelopathy. Receives: Device: Anterior Cervical Discectomy and 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
Standardized Neurological Assessment Scales
Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline
Measured: 24 month
Secondary Surgical Intervention
No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index levels
Measured: 24 month
Device Related Adverse Event
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-36
Health Survey (SF-36) at baseline and at each follow-up time-point
Measured: pre-operative, 6 week, 3 month, 6 month, 12 month, 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: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Patient Satisfaction
Patient Satisfaction Questionnaire
Measured: 6 week, 3 month, 6 month, 12 month, 24 month
BZ Score
Bazaz Dysphagia Score at 24 months compared to baseline
Measured: 6 week, 3 month, 6 month, 12 month, 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 month, 6 month, 12 month, 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Jun 2023
- Primary completionNov 2026 (estimated)
- Study completionDec 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
- multicenter, prospective, historically controlled
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synergy Spine Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
- Investigators
- Josh Butters, ME, MBA, Study director, Synergy Spine Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740176
- Sponsor's protocol ID
- CP 110-0004
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. 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 Two-Level Symptomatic Cervical Degenerative Disc Disease (DDD)
- ClinicalTrials.gov ID
- NCT05740176
- Acronym / sponsor ID
- CP 110-0004
- Conditions
- Cervical Degenerative Disc Disease
- Keywords
- degenerative disc disease, cervical, artificial disc replacement, motion preservation, motion preservation disc, cervical TDR
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Synergy Spine SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Feb 2023 (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. To 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 two levels from C3 to C7 are and are unresponsive to conservative management. Patients will be evaluated preoperatively, at the time of surgery, and at 6 weeks, and 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
This is a research study comparing two ways of treating neck problems caused by degenerative disc disease (wear-and-tear damage to the discs that cushion the bones in the neck).
The study is comparing:
The Synergy Disc - an artificial disc device being studied in this trial, and Standard surgery (ACDF) - a widely used procedure called anterior cervical discectomy and fusion, which is the accepted current treatment.
Up to 200 people will receive the Synergy Disc as part of this study. Their results will be compared to results from people who had the standard ACDF surgery in the past, rather than assigning some people to get ACDF during this study (this is called a "historical control"). The study takes place at multiple medical centers.
Who this study is for:
People who are fully grown (skeletally mature) and have damage in two neighboring discs in the neck (located somewhere between the C3 and C7 vertebrae). To qualify, a person's symptoms must include:
Arm pain and/or nerve-related weakness or numbness (radiculopathy) that hasn't improved, and Neck pain or signs of spinal cord compression (myelopathy)
These symptoms must be caused by problems in the two affected disc levels, and must not have gotten better with non-surgical treatment (such as physical therapy, medication, or injections).
What the study will measure:
Whether the Synergy Disc is as safe and effective as standard ACDF surgery for people who need surgery to relieve pressure on the nerves or spinal cord at two neighboring disc levels in the neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multicenter, prospective, historically controlled
| Arm | Type | Receives |
|---|---|---|
| Synergy Disc | Experimental | Device: Anterior Cervical Discectomy and 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 restore kinematics to the cervical spine. The Synergy Disc is intended for use in the cervical spine for reconstruction of the disc following a two level discectomy for intractable radiculopathy and/or myelopathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- In order to be eligible to participate in this study, subjects must meet all of the following criteria:
- Must be at least 18 years of age and be skeletally mature at the time of surgery
- Has a preoperative neck pain score ≥ 8 (out of 20) based on the preoperative Neck and Arm Pain Questionnaire.
- Has cervical degenerative disc disease at two (2) adjacent cervical levels (from C3 - C7) requiring surgical treatment and involving intractable radiculopathy, myelopathy, or both;
- Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history (e.g., neck pain with arm pain, functional deficit and/or neurological deficit), and the requirement for surgical treatment is evidenced by radiographic studies (e.g., CT, MRI, x-rays, etc.);
Key exclusion criteria (24 listed)
- Subjects who meet any of the following criteria will be excluded from participation in this study:
- Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels;
- Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing:
- 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);
- Has severe pathology of the facet joints of the involved vertebral bodies;
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 and FusionAlso: ACDFAnterior cervical discectomy is a surgical procedure that was developed to treat damaged cervical discs by relieving pressure on the nerve roots or on the spinal cord by removing the ruptured disc. The operation is performed by reaching the cervical spine through a small incision in the front of the neck. The soft tissues of the neck are then separated allowing for the disc to be removed. Anterior cervical discectomy has proven to be a safe and effective procedure for the treatment of degenerative disc disease. The anterior approach allows direct visualization of the entire interspace and wide decompression of the anterior aspect cervical spinal cord and nerve roots. It may be undertaken in cases of multilevel disease and interbody fusion may be performed if required | 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
Standardized Neurological Assessment Scales
Time frame: 24 month
Maintenance or improvement in neurological status (motor and sensory only) at 24 months compared to baseline
Secondary Surgical Intervention
Time frame: 24 month
No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index levels
Device Related Adverse Event
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-36
Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
VAS
Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Patient Satisfaction
Time frame: 6 week, 3 month, 6 month, 12 month, 24 month
BZ Score
Time frame: 6 week, 3 month, 6 month, 12 month, 24 month
Odom's Criteria
Time frame: 6 week, 3 month, 6 month, 12 month, 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 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Josh Butters, ME, MBA study director
Synergy Spine Solutions
23 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 and Fusion in people with Cervical Degenerative Disc Disease, run by Synergy Spine Solutions at 23 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 9 inclusion and 24 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 2 Nov 2026.