Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes

NCT ID: NCT03218150

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-10-31

Brief Summary

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

Detailed Description

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.

Conditions

Cerebral Decompression Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

bone cement group

patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis

cranioplasty

Intervention Type: 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.

titanium mesh group

patient underwent to cranioplasty reconstruction with titanium mesh

cranioplasty

Intervention Type: 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.

autologous bone group

patient underwent to cranioplasty reconstruction with autologous bone graft

cranioplasty

Intervention Type: 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.

Interventions

cranioplasty

. 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. All patients that have reconstructive surgery of cranial defects due to traumatic or lesion resection causes .

2. Age older than 10 and less than 60 years

3. Provided written informed consent

Exclusion Criteria

1. Cases of cranial defects due to congenital anomalies or growing skull fractures .

2. Severe disease with limited life expectancy of less than one year

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Alaeddin Mohamed Ali

resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Assiut cranioplasty

Identifier Type: -

Identifier Source: org_study_id