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Clinical Trial 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 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.


Clinical Trial 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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01641523
Study type Observational
Source Azienda Ospedaliero-Universitaria di Parma
Contact
Status Completed
Phase N/A
Start date January 2007
Completion date September 2011

See also
  Status Clinical Trial Phase
Recruiting NCT04111562 - Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects N/A
Recruiting NCT06097845 - Transcranial Ultrasound Via Sonolucent Cranioplasty N/A
Terminated NCT00923793 - Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty Phase 3
Enrolling by invitation NCT05362370 - Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness