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:
- Functional improvement of 20% at 24 months post-operative, compared to the pre-operative status, evaluated by the Neck Disability Index (NDI).
- Neurological improvement: conservation of or improvement in three main components of the neurological status: motor functions, reflexes, sensibility.
- Neck and Arm Pain: pain relief of 20% at 24 months post-operative, compared to the pre-operative status, evaluated by VAS scores.
- Improvement in Health-related Quality of Life of 15% at 24 months post-operative, compared to the pre-operative status, assessed using the Short-Form-36 questionnaire (SF-36 scores)
- 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