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NCT04012996 · ClinicalTrials.gov registry record · NA
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
A NA study of Symptomatic Cervical Disc Disease, sponsored by Centinel Spine.
- Active
- Registry status
- NA
- Development phase
- 390
- Enrollment target
- 20
- Study locations
NCT04012996 is a NA study of Symptomatic Cervical Disc Disease that is active but no longer recruiting, run by Centinel Spine. The registered enrollment target is 390 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT04012996, a NA study of Symptomatic Cervical Disc Disease, is active but no longer recruiting, sponsored by Centinel Spine.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 390 participants
- Enrollment target
- 20
- Study locations
Study Summary
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).
Conditions Studied
Interventions
- DEVICE prodisc C SK and/or Vivo
- DEVICE Mobi-C Cervical Disc
Study Locations (20)
California
- Todd Lanman, MD, Inc. - Beverly Hills
- Doctors Outpatient Center for Surgery - Los Angeles
- Sutter Health - Palo Alto Medical Foundation - Palo Alto
- Sutter Health - Sacramento
Florida
- St. Vincent's Neurosurgery - Jacksonville
- Kennedy-White Orthopaedic Center - Sarasota
- University of South Florida - Tampa
- Florida Orthopaedic Institute - Temple Terrace
Colorado
- HCA Healthcare - Lone Tree
- Sky Ridge Medical Center Campus - Lone Tree
- Center for Spine and Orthopedics, Scientific Education and Research Foundation - Thornton
Arizona
- Flagstaff Bone and Joint - Flagstaff
District of Columbia
- Georgetown University Hospital - Washington D.C.
Indiana
- Indiana Spine Group - Carmel
Kentucky
- Orthopaedic Institute of Western Kentucky - Paducah
Louisiana
- Spine Institute of Louisiana - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2019-08-05 |
| Est. Completion | 2028-05-13 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04012996
The ClinicalTrials.gov registry entry for NCT04012996 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centinel Spine, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Symptomatic Cervical Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which prodisc C SK and/or Vivo is the first listed.
NCT04012996 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT04012996 about?
NCT04012996 is a clinical study titled "2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C". A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).
What is the current status of trial NCT04012996?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 390 participants. The study started on 2019-08-05. Estimated completion is 2028-05-13.
What conditions does trial NCT04012996 study?
This clinical trial studies the following conditions: Symptomatic Cervical Disc Disease.
What interventions are being tested in trial NCT04012996?
The interventions under investigation include: prodisc C SK and/or Vivo (DEVICE), Mobi-C Cervical Disc (DEVICE).
Who is sponsoring clinical trial NCT04012996?
This trial is sponsored by Centinel Spine, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04012996 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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