Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes

Cerebral Decompression Injury Clinical Trial

Official title:

Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03218150
• Other study ID #: Assiut cranioplasty
• Status: Active, not recruiting
• Phase: N/A
• First received: July 11, 2017
• Last updated: July 12, 2017
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: July 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: October 2018
• Est. primary completion date: March 2018
• Gender: All
• Age group: 10 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Decompression Injury

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety : minimize incidence of infection	incidence of adverse events ((infection, reabsorption))	360 days after surgery
Secondary	efficacy	quality of life improvement evaluation : (( glasgow coma score))	60 , 120 , 360 days after surgery