A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERA C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at Two Contiguous Levels
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cervical Disc Disease
- Sponsor
- Spineart USA
- Enrollment
- 300
- Locations
- 26
- Primary Endpoint
- Procedure or device related serious adverse events
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
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) at two contiguous levels. Subjects will be randomized in a 2:1 ratio to the two-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the two-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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Procedure or device related serious adverse events
Time Frame: 24 month follow-up visit
No serious adverse event(s) confirmed as device or procedure related as adjudicated by the Clinical Events Committee
Neck Disability Index
Time Frame: 24 month follow-up visit
at least a 15 percentage point improvement (decrease) from baseline on a 0 - 100% scale
No secondary surgical intervention per protocol definition
Time Frame: 24 month follow-up visit
any revision, removal, re-operation, or supplemental fixation at the index level
Maintenance or improvement in neurological status
Time Frame: 24 month follow-up visit
pre and post-op neurological examination to determine maintenance or improvement