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Controlled Study in Cranioplasty Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01641523
Recruitment Status : Completed
First Posted : July 16, 2012
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

Multicenter, prospective, comparative, observational study with regular follow-up visits.

The project's aim is long-term follow-up of patients affected by large and complex craniolacuniae treated, in standard clinical practice, with CustomBone Service™ Cranial (porous bio-mimetic hydroxyapatite custom-made medical device for cranioplasty), autologous bone or polymethilmethacrylate customized prosthesis and to compare the clinical outcome and safety among the three treatments.

Elegibility to each treatment will respect the standard clinical practice. Each investigator will respect his own hospital criteria for cranial reconstruction.

Each centre's agreement to participate the study is totally voluntary.

The study sample size has not been defined on statistical criteria: the study population was set at 100 consecutive patients treated with cranioplasty reconstruction with one of the three foreseen group.

Each investigator will not be allowed to enrol more then 20 patients to avoid an enrolment imbalance between centres involved.

Primary study end-points are: evaluation of adverse event incidence after surgical treatment.

Secondary end-points are: quality of life improvement, evaluation of bone continuity restoration evaluated by CT scan analysis, neurological improvement.

Condition or disease Intervention/treatment
Cerebral Decompression Injury Cranioplasty Device: CustomBone Service

Detailed Description:

Cranioplasty surgery is necessary everytime a craniolacuniae has to be reconstructed to ensure protection to the central nervous system. Cranioplasty surgery is classified into first line surgery, due to traumatic events or degenerative pathologies, and second line treatment, when due to first treatment failure, for example because of autologous bone reabsorption/infection or other material reject.

Clinical evaluation scores Specific and validated clinical scores will be employed for End-points evaluation.

CT scan will required in the pre-operation visit and in the post-operation time during the follow up visits to evaluate the bone-implant osteointegration process and osteointegration will be evaluated applying a specific score.

Data have been recorded in a e-CRF with limited access, protected by personal password.

Data will always be collected in an anonymous way, subjects identity will always be undisclosed.

Each patient will be asked to give informed consent to partecipate the study.

Study Design

Study Type : Observational
Actual Enrollment : 91 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Prospective Controlled Study in Cranioplasty Reconstruction
Study Start Date : January 2007
Primary Completion Date : January 2007
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Hydroxyapatite Cranioplasty
patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis
Device: CustomBone Service
customized hydroxyapatite cranial prosthesis
Other Names:
  • polymethylmethacrylate cranioplasty
  • autologous bone opercula
patient underwent to cranioplasty reconstruction with polymethylmethacrylate prosthesis
Device: CustomBone Service
customized hydroxyapatite cranial prosthesis
Other Names:
  • polymethylmethacrylate cranioplasty
  • autologous bone opercula
autologous bone
patients underwent to cranioplasty reconstruction by autologous bone repositioning
Device: CustomBone Service
customized hydroxyapatite cranial prosthesis
Other Names:
  • polymethylmethacrylate cranioplasty
  • autologous bone opercula

Outcome Measures

Primary Outcome Measures :
  1. Safety [ Time Frame: 360 day after surgery ]
    incidence of adverse event (infection, reabsorption, mobilization, fractures, dislocation) after surgical treatment

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 90, 180, 360, 720 days after the surgery ]
    Quality of life improvement evaluation: Disability Rating Scale(DRS); Neurological recovery evaluation: Neurological Objective Exam (EON), Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GCS), motor deficit evaluation scale; Mechanical, biological and aesthetic outcome; CT scan evaluation;

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
consecutive patients,in different italian centres, requiring cranioplasty

Inclusion Criteria:

  1. Patients which need cranial reconstruction,
  2. Cranioplasty reconstruction by autologous bone, hidroxyapatite or polymethylmethacrylate,
  3. Patients of both sex in age range between 14 and 75 years old,
  4. Craniolacuniae size > 25 cm2 ,
  5. Patients affected by complex pathologies or fracture or infection of a previous implant.
  6. Elegibility to CustomBone Service™ Cranial treatment will respect the product leaflet instructions.
  7. Each investigator will respect his own medical centre internal inclusion criteria to cranial reconstruction.

Exclusion Criteria:

  1. Patients affected by important emocoagulation pathologies,
  2. Patients affected by mellitus diabetes,
  3. Patients affected by autoimmune pathology,
  4. Patients unable to intend,
  5. Patients affected by immunodepression.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641523

Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
Fin-Ceramica Faenza Spa
Study Director: Franco Servadei, Prof. MD Maggiore Hospital Parma
More Information

Responsible Party: Franco Servadei, Franco Servadei, Prof. MD, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT01641523     History of Changes
Other Study ID Numbers: NEU02
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by Franco Servadei, Azienda Ospedaliero-Universitaria di Parma:
Cranioplasty prosthesis
Autologous Bone

Additional relevant MeSH terms:
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs