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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164
Last updated 2025-12-17
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
Interventions
- DEVICE
-
Triadyme-C
Triadyme-C Cervical Total Disc Replacement
Sponsors & Collaborators
-
Dymicron
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-01-05
- Primary Completion
- 2029-07-31
- Completion
- 2029-07-31
- FDA Device
- Yes
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