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 range21 Years
SexALL
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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.
✓. 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.