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BAGUERA ® C - 1 Pages

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BAGUERA ® C

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BAGUERA®C Study #16001 Cervical Arthroplasty using BAGUERA® C: A two-year, prospective, clinical follow-up data registry. Retrospective clinical analysis results Not FDA approved. Non-US study Region: Europe Status: Completed Pilot study for registration in various countries Primary Objectives: Safety Evaluation: Evaluation at the end of 2 years post-operative follow-up of the safety of the BAGUERA®C cervical disc prosthesis by analyzing all adverse events reported during the observation period, whether anticipated or unanticipated, related or not to the use of the device. Effectiveness Evaluation: An overall success rate was defined as a composite primary endpoint, based on individual overall success evaluated for each subject at 24 months post-operative, based on five parameters taken from clinical and safety evaluation: 1. Functional improvement of 20% at 24 months post-operative, compared to the pre-operative status, evaluated by the Neck Disability Index (NDI). 2. Neurological improvement: conservation of or improvement in three main components of the neurological status: motor functions, reflexes, sensibility. 3. Neck and Arm Pain: pain relief of 20% at 24 months post-operative, compared to the pre-operative status, evaluated by VAS scores. 4. Improvement in Health-related Quality of Life of 15% at 24 months postoperative, compared to the pre-operative status, assessed using the Short-Form36 questionnaire (SF-36 scores) 5. No subsequent surgery. Indication - condition: Symptomatic cervical degenerative disc disease one or two levels from C3 to C7 Study type: Observational, prospective data collection (registry), retrospective analysis, multicenter cohort study Patients enrolled: 118 Primary outcomes: • NDI scores • Adverse events: - Duration (starts and end dates), - Seriousness, Intensity, Severity, Anticipated/Unanticipated - Relationship to the implant (suspected/not suspected), - Re-interventions, Revisions, - Relationship to the surgery (suspected/not suspected), - Removals or supplemental fixation. • Neck and Arm Pain by Visual Analogic Scale (VAS) • Neurological status: motor functions, reflexes, sensibility • SF-36 scores

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