A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Single Level Cervical Disc Disease
- Conditions
- Cervical Disc Disease
- Registration Number
- NCT04520776
- Lead Sponsor
- Spineart USA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 284
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Neck Disability Index 24 month follow-up visit at least a 15 percentage point improvement (decrease) from baseline
No secondary surgical intervention per protocol definition 24 month follow-up visit any revision, removal, re-operation, or supplemental fixation at the index level
Maintenance or improvement in neurological status 24 month follow-up visit pre and post-op neurological examination to determine maintenance or improvement
Procedure or device related serious adverse events 24 month follow-up visit No serious adverse event(s) confirmed as device or procedure related as adjudicated by the Clinical Events Committee
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
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
Scroll for more (17 remaining)MORE Foundation🇺🇸Phoenix, Arizona, United States