Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes

NCT03218150 | Unknown

• 1 other identifier: Assiut cranioplasty
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cerebral Decompression Injury

Outcome Measures

Primary Outcomes (1)

• safety : minimize incidence of infection

  incidence of adverse events ((infection, reabsorption))

  360 days after surgery

Secondary Outcomes (1)

• efficacy

  60 , 120 , 360 days after surgery

Study Arms (3)

bone cement group

patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis

Procedure: cranioplasty

titanium mesh group

patient underwent to cranioplasty reconstruction with titanium mesh

Procedure: cranioplasty

autologous bone group

patient underwent to cranioplasty reconstruction with autologous bone graft

Procedure: cranioplasty

Interventions

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.

autologous bone group; bone cement group; titanium mesh group

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patient's that need cranioplasty surgery admitted in assiut university hospital

You may qualify if:

• All patients that have reconstructive surgery of cranial defects due to traumatic or lesion resection causes .
• Age older than 10 and less than 60 years
• Provided written informed consent

You may not qualify if:

• Cases of cranial defects due to congenital anomalies or growing skull fractures .
• Severe disease with limited life expectancy of less than one year

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 14, 2017
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: October 1, 2018
• Last Updated: July 14, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share