Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bone cement group | patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis |
| |
| titanium mesh group | patient underwent to cranioplasty reconstruction with titanium mesh |
| |
| autologous bone group | patient underwent to cranioplasty reconstruction with autologous bone graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cranioplasty | Procedure | . The margins of the craniectomy defects exposed, and the bone flaps fixed in their original positions using wires or titanium plates with screws. As prophylaxis, all patients intravenously administered with pre- and postoperative antibiotics. In cases of artificial substitutes , The polymethyemethacrylate implant fixed to the defective region with titanium plates and self-tapping screws. |
| Measure | Description | Time Frame |
|---|---|---|
| safety : minimize incidence of infection | incidence of adverse events ((infection, reabsorption)) | 360 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy | quality of life improvement evaluation : (( glasgow coma score)) | 60 , 120 , 360 days after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patient's that need cranioplasty surgery admitted in assiut university hospital
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|