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

NCT07287449 | Not Yet Recruiting FDA Device

• 1 other identifier: PRO-22012
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief 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 conservative management.

Conditions

Cervical Disc Disease

Outcome Measures

Primary Outcomes (4)

• Composite Clinical Success

  At least 15-point improvement in NDI Score (out of 100) compared with baseline.

  24 months

• Composite Clinical Success

  Maintenance or improvement in neurological status (motor and sensory only) compared to baseline as adjudicated by the CEC.

  24 months

• Composite Clinical Success

  No secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level.

  24 months

• Composite Clinical Success

  Absence of serious device-related adverse events, as adjudicated by the CEC.

  24 months

Secondary Outcomes (5)

• Clinically Significant Improvement

  6 weeks

• Clinically Significant Improvement

  3 months

• Clinically Significant Improvement

  6 months

• Clinically Significant Improvement

  12 months

• Clinically Significant Improvement

  24 months

Study Arms (1)

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.

Device: Triadyme-C

Interventions

Triadyme-C DEVICE

Triadyme-C Cervical Total Disc Replacement

Safety and Effectiveness of Triadyme-C

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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 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.

Sponsors & Collaborators

• Dymicron: lead

Central Study Contacts

Jeffrey Bennett

CONTACT

804-536-0596; jabennett@dymicron.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 17, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12