Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes

• Conditions: Cerebral Decompression Injury
• Interventions: Procedure: cranioplasty

• Registration Number: NCT03218150
• Lead Sponsor: Assiut University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-10
• Status Verified: 2017-07
• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Study First Posted: 2017-07-14
• Last Update Posted: 2017-07-14
• Primary Completion: 2018-03
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bone cement group	cranioplasty	patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis
titanium mesh group	cranioplasty	patient underwent to cranioplasty reconstruction with titanium mesh
autologous bone group	cranioplasty	patient underwent to cranioplasty reconstruction with autologous bone graft

Primary Outcome Measures

Name	Time	Method
safety : minimize incidence of infection	360 days after surgery	incidence of adverse events ((infection, reabsorption))

Secondary Outcome Measures

Name	Time	Method
efficacy	60 , 120 , 360 days after surgery	quality of life improvement evaluation : (( glasgow coma score))