View clinical trials related to Cerebral Decompression Injury.
Filter by: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
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.