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.
Male or female subject, age ≥21.
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
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.
Single group
Triadyme-C
DeviceTriadyme-C Cervical Total Disc Replacement
Composite Clinical Success
At least 15-point improvement in NDI Score (out of 100) compared with baseline.
Composite Clinical Success
Maintenance or improvement in neurological status (motor and sensory only) compared to baseline as adjudicated by the CEC.
Composite Clinical Success
No secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level.
Composite Clinical Success
Absence of serious device-related adverse events, as adjudicated by the CEC.
Clinically Significant Improvement
Clinically significant improvement in one or more radicular symptoms or myelopathy at each timepoint compared to baseline.
Clinically Significant Improvement
Clinically significant improvement in one or more radicular symptoms or myelopathy at each timepoint compared to baseline.
Clinically Significant Improvement
Clinically significant improvement in one or more radicular symptoms or myelopathy at each timepoint compared to baseline.
Clinically Significant Improvement
Clinically significant improvement in one or more radicular symptoms or myelopathy at each timepoint compared to baseline.
This trial is not recruiting at the moment. You can still explore other options:
