A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Single Level Cervical Disc Disease
Status unconfirmed · Not applicable
Conditions studied: Cervical Disc Disease
In brief
The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD). Subjects will be randomized in a 2:1 ratio to the one-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the one-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.
Key facts
- Study ID
- NCT04520776
- Run by
- Spineart USA
- People needed
- 284
- Starts
- 2021-03-02
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2024-05-29
Who can join
Age: 22 and older, up to 69. Sex: any. Healthy volunteers: not accepted.
Where it is running
- MORE Foundation — Phoenix, Arizona, United States
- Desert Institute for Spine Care — Scottsdale, Arizona, United States
- BEEL Medical — Laguna Hills, California, United States
- Orange County Neurosurgical Associates — Mission Viejo, California, United States
- The Huffman Clinic at Napa Valley Orthopaedic Group — Napa, California, United States
- UCI Health — Orange, California, United States
- Eisenhower Medical Center — Rancho Mirage, California, United States
- The Spine Institute, Center for Spine Restoration — Santa Monica, California, United States
- The Institute of Neuro Innovation — West Hills, California, United States
- Vail-Summit Orthopaedics and Neurosurgery — Vail, Colorado, United States
- Hartford Healthcare CT Orthopaedics — Hamden, Connecticut, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Legacy Brain & Spine — Atlanta, Georgia, United States
- Midwest Orthopedics at RUSH — Chicago, Illinois, United States
- NorthShore University — Evanston, Illinois, United States
- Indiana Spine Group — Carmel, Indiana, United States
- Ortho NorthEast — Fort Wayne, Indiana, United States
- Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States
- Spine Institute of Louisiana — Shreveport, Louisiana, United States
- Carolina Neurosurgery and Spine Associates — Charlotte, North Carolina, United States
- The Ohio Sate University - Dept of Orthopedics — Columbus, Ohio, United States
- Oregon Spine Care — Tualatin, Oregon, United States
- Neurosurgical Associates of Lancaster — Lancaster, Pennsylvania, United States
- Center for Sports Medicine & Orthopedics — Chattanooga, Tennessee, United States
- St. David's Healthcare — Austin, Texas, United States
Full record on ClinicalTrials.gov
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