Cervical Disc DiseaseNCT07287449
A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level
A study testing Triadyme-C in people with Cervical Disc Disease, run by Dymicron.
Trial summary
A multicenter, prospective, historically controlled study to evaluate the safety and effectiveness of the Triadyme-C device in comparison to other approved TDRs in the treatment of symptomatic cervical disc disease (SCDD) in subjects who are symptomatic at only a single level from C3 to C7 that are unresponsive to… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Disc Disease
- What is being tested?
- Triadyme-C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2026to 31 Jul 2029
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subject, age ≥21.
- Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesia or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
- Neck and/or arm pain (at least 30 mm on the 100 mm visual analogue scale [VAS] scale).
- Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
- Abnormal sensation including hyperesthesia or hypoesthesia; and/or
- Abnormal reflexes.
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- Symptomatic at a single level from C3 to C7.
- Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
- Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.
- Degenerative spondylosis on CT or MRI.
- Disc herniation on CT or MRI.
- Neck Disability Index (NDI) Score ≥ 30 (out of 100).
- Unresponsive to non-operative, conservative treatment (e.g., rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
- At least six weeks from radiculopathy or myeloradiculopathy symptom onset; or
- Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment.
- Appropriate for treatment using an anterior surgical approach.
- Reported to be medically cleared for surgery.
- Reported to be physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
- Written informed consent provided by subject.
Who cannot join
- Have an active systemic infection or infection at the operative site.
- Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
- Have more than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
- Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
- Prior attempted or completed cervical spine surgery at any cervical level, except (1) a minimally invasive decompression that did not de-stabilize the segment upon flexion/extension or (2) a successful single-level anterior cervical fusion at non-index level (greater than 6 months prior to scheduled surgical treatment).
- Have axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention.
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- Have disc height less than 3 mm as measured from the center of the disc in a neutral position.
- Evidence of symptomatic moderate to severe facet joint degeneration or disease where the investigator feels this is a major contributor to the subject's pain as diagnosed by injection and imaging.
- Have osteoporosis or is an increased risk of osteoporosis/osteopenia defined as a T-score less than -1.5 (i.e., -1.6, -1.7, etc.).
- The SCORE/MORES will be used to screen if a dual energy X-ray absorptiometry (DEXA) scan is required. If SCORE/MORES value ≥ 6, then a DEXA is required.
- An existing DEXA is allowed if completed within 12 months of subject surgery.
- Have diabetes mellitus requiring daily insulin management.
- Have severe myelopathy to the extent that the patient is wheelchair bound.
- Have Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis, which is addressed above (i.e., Exclusion #9).
- Have active malignancy that includes a history of any invasive malignancy (except non-melanoma skin cancer) unless the subject had been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least five years.
- Have tumor as source of symptoms.
- Have Symptomatic Cervical Degenerative Disc Disease (SDDD) or significant cervical spondylosis at two or more levels.
- Have spondylolysis.
- Have arachnoiditis.
- Have marked cervical instability on resting (neutral) lateral or flexion-extension radiographs demonstrated by:
- Translation ≥ 3.5 mm, and/or
- Greater than 11° angular difference to that of either adjacent level.
- Have a known allergy to implant materials (titanium, Ti-6Al-4V alloy, TiC, or SnCoCrMo alloy).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A multicenter, prospective, historically controlled study to evaluate the safety and effectiveness of the Triadyme-C device in comparison to other approved TDRs in the treatment of symptomatic cervical disc disease (SCDD) in subjects who are symptomatic at only a single level from C3 to C7 that are unresponsive to conservative management.
- Conditions
- Cervical Disc Disease
- Being tested
- Triadyme-C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triadyme-CDevice
Triadyme-C Cervical Total Disc Replacement
| Study group | Role | What they receive |
|---|---|---|
| Safety and Effectiveness of Triadyme-C | Experimental | To evaluate the safety and effectiveness of the Triadyme-C device in comparison to other approved TDRs in the treatment of symptomatic cervical disc disease (SCDD) in subjects who are symptomatic at only a single level from C3 to C7 that are unresponsive to conservative management. Receives: Device: Triadyme-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical Success
At least 15-point improvement in NDI Score (out of 100) compared with baseline.
Measured: 24 months
Composite Clinical Success
Maintenance or improvement in neurological status (motor and sensory only) compared to baseline as adjudicated by the CEC.
Measured: 24 months
Composite Clinical Success
No secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level.
Measured: 24 months
Composite Clinical Success
Absence of serious device-related adverse events, as adjudicated by the CEC.
Measured: 24 months
Secondary outcomes (5)
Clinically Significant Improvement
Clinically significant improvement in one or more radicular symptoms or myelopathy at each timepoint compared to baseline.
Measured: 6 weeks
Clinically Significant Improvement
Clinically significant improvement in one or more radicular symptoms or myelopathy at each timepoint compared to baseline.
Measured: 3 months
Clinically Significant Improvement
Clinically significant improvement in one or more radicular symptoms or myelopathy at each timepoint compared to baseline.
Measured: 6 months
Clinically Significant Improvement
Clinically significant improvement in one or more radicular symptoms or myelopathy at each timepoint compared to baseline.
Measured: 12 months
Clinically Significant Improvement
Clinically significant improvement in one or more radicular symptoms or myelopathy at each timepoint compared to baseline.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start5 Jan 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dymicron
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287449
- Sponsor's protocol ID
- PRO-22012
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level
- ClinicalTrials.gov ID
- NCT07287449
- Acronym / sponsor ID
- PRO-22012
- Conditions
- Cervical Disc Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- DymicronIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 17 Dec 2025 (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, historically controlled study to evaluate the safety and effectiveness of the Triadyme-C device in comparison to other approved TDRs in the treatment of symptomatic cervical disc disease (SCDD) in subjects who are symptomatic at only a single 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
| Arm | Type | Receives |
|---|---|---|
| Safety and Effectiveness of Triadyme-C | Experimental | Device: Triadyme-CTo evaluate the safety and effectiveness of the Triadyme-C device in comparison to other approved TDRs in the treatment of symptomatic cervical disc disease (SCDD) in subjects who are symptomatic at only a single level from C3 to C7 that are unresponsive to conservative management. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female subject, age ≥21.
- Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesia or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
- Symptomatic at a single level from C3 to C7.
- Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
- Neck Disability Index (NDI) Score ≥ 30 (out of 100).
Key exclusion criteria (23 listed)
- Have an active systemic infection or infection at the operative site.
- Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
- Have more than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
- Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
- Prior attempted or completed cervical spine surgery at any cervical level, except (1) a minimally invasive decompression that did not de-stabilize the segment upon flexion/extension or (2) a successful single-level anterior cervical fusion at non-index level (greater than 6 months prior to scheduled surgical treatment).
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 |
|---|---|---|
| Triadyme-CTriadyme-C Cervical Total Disc Replacement | Device | Safety and Effectiveness of Triadyme-C |
Primary outcome
Composite Clinical Success
Time frame: 24 months
At least 15-point improvement in NDI Score (out of 100) compared with baseline.
Composite Clinical Success
Time frame: 24 months
Maintenance or improvement in neurological status (motor and sensory only) compared to baseline as adjudicated by the CEC.
Composite Clinical Success
Time frame: 24 months
No secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level.
Composite Clinical Success
Time frame: 24 months
Absence of serious device-related adverse events, as adjudicated by the CEC.
5 secondary outcomes
Clinically Significant Improvement
Time frame: 6 weeks
Clinically Significant Improvement
Time frame: 3 months
Clinically Significant Improvement
Time frame: 6 months
Clinically Significant Improvement
Time frame: 12 months
Clinically Significant Improvement
Time frame: 24 months
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 17 Dec 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.
Questions about this trial
What is this clinical trial studying?
A study testing Triadyme-C in people with Cervical Disc Disease, run by Dymicron.
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 19 inclusion and 23 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: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jeffrey Bennett (804-536-0596, jabennett@dymicron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Clinical Success (time frame: 24 months). 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 17 Dec 2025.