A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effec… (NCT07287449) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
164 participantsStarted 2026-01-05
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
Exclusion criteria
. 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.