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:

- 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