Cranioplasty Clinical Trial
Official title:
Multicenter Prospective Controlled Study in Cranioplasty Reconstruction
Multicenter, prospective, comparative, observational study with regular follow-up visits.
The project's aim is long-term follow-up of patients affected by large and complex
craniolacuniae treated, in standard clinical practice, with CustomBone Serviceā¢ Cranial
(porous bio-mimetic hydroxyapatite custom-made medical device for cranioplasty), autologous
bone or polymethilmethacrylate customized prosthesis and to compare the clinical outcome and
safety among the three treatments.
Elegibility to each treatment will respect the standard clinical practice. Each investigator
will respect his own hospital criteria for cranial reconstruction.
Each centre's agreement to participate the study is totally voluntary.
The study sample size has not been defined on statistical criteria: the study population was
set at 100 consecutive patients treated with cranioplasty reconstruction with one of the
three foreseen group.
Each investigator will not be allowed to enrol more then 20 patients to avoid an enrolment
imbalance between centres involved.
Primary study end-points are: evaluation of adverse event incidence after surgical
treatment.
Secondary end-points are: quality of life improvement, evaluation of bone continuity
restoration evaluated by CT scan analysis, neurological improvement.
Cranioplasty surgery is necessary everytime a craniolacuniae has to be reconstructed to
ensure protection to the central nervous system. Cranioplasty surgery is classified into
first line surgery, due to traumatic events or degenerative pathologies, and second line
treatment, when due to first treatment failure, for example because of autologous bone
reabsorption/infection or other material reject.
Clinical evaluation scores Specific and validated clinical scores will be employed for
End-points evaluation.
CT scan will required in the pre-operation visit and in the post-operation time during the
follow up visits to evaluate the bone-implant osteointegration process and osteointegration
will be evaluated applying a specific score.
Data have been recorded in a e-CRF with limited access, protected by personal password.
Data will always be collected in an anonymous way, subjects identity will always be
undisclosed.
Each patient will be asked to give informed consent to partecipate the study.
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Observational Model: Cohort, Time Perspective: Prospective
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