Controlled Study in Cranioplasty Reconstruction
Condition: Cerebral Decompression Injury; Cranioplasty
Study type: Observational

Summary: 
      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 Service™ 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.
    

Detailed description: 
      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.
    

Intervention name(s): CustomBone Service
Intervention type(s): Device
Intervention description(s): customized hydroxyapatite cranial prosthesis
Other intervention name(s): polymethylmethacrylate cranioplasty; autologous bone opercula
Intervention MeSH terms: Polymethyl Methacrylate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        consecutive patients,in different italian centres, requiring cranioplasty
      
Keywords: Cranioplasty prosthesis; Hydroxyapatite; PolyMethylMethacrylate; Autologous Bone