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Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alaeddin Mohamed Ali, Assiut University
ClinicalTrials.gov Identifier:
NCT03218150
First received: July 11, 2017
Last updated: July 12, 2017
Last verified: July 2017
  Purpose

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


Condition Intervention
Cerebral Decompression Injury Procedure: cranioplasty

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes

Resource links provided by NLM:


Further study details as provided by Alaeddin Mohamed Ali, Assiut University:

Primary Outcome Measures:
  • safety : minimize incidence of infection [ Time Frame: 360 days after surgery ]
    incidence of adverse events ((infection, reabsorption))


Secondary Outcome Measures:
  • efficacy [ Time Frame: 60 , 120 , 360 days after surgery ]
    quality of life improvement evaluation : (( glasgow coma score))


Enrollment: 1
Study Start Date: October 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
bone cement group
patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis
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.

titanium mesh group
patient underwent to cranioplasty reconstruction with titanium mesh
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.

autologous bone group
patient underwent to cranioplasty reconstruction with autologous bone graft
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.


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.

  Eligibility

Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patient's that need cranioplasty surgery admitted in assiut university hospital
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Alaeddin Mohamed Ali, resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03218150     History of Changes
Other Study ID Numbers: Assiut cranioplasty
Study First Received: July 11, 2017
Last Updated: July 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on July 24, 2017