Cerebral Decompression Injury Clinical Trial
Official title:
Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes
Prospective, comparative, observational study.
The project's aim is long term follow up of patient's having skull bone defects due to
traumatic or lesion resection causes, treated , in standard clinical practice, with
autologous bone graft , bone cement or titanium mesh and to compare the clinical outcome and
safety among the 3 types of treatment.
Eligibility to each treatment will respect the standard clinical practice.
Primary outcome: minimize post operative infection
Secondary outcomes: decrease operation time , clinical and psychological improvement of the
patient, decrease the cost on the patient
Cranioplasty is the surgical intervention to repair cranial defects. The aim of cranioplasty
is not only a cosmetic issue; also, the repair of cranial defects gives relief to
psychological drawbacks and increases the social performances. Many different types of
materials were used throughout the history of cranioplasty. With the evolving biomedical
technology, new materials are available to be used by the surgeons. Although many different
materials and techniques had been described, ongoing researches on both biologic and non
biologic substitutions continue aiming to develop the ideal reconstruction material.
Autologous bone grafts remain the best option for adult and pediatric patients with viable
donor sites and small-to-medium defects. Large defects in the adult population can be
reconstructed with titanium mesh and polymethylmethacrylate overlay with or without the use
of computer-assisted design and manufacturing customization. Advances in alloplastic
materials and custom manufacturing of implants will have an important influence on
cranioplasty techniques in the years to come.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01641523 -
Controlled Study in Cranioplasty Reconstruction
|
N/A |