- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01641523
Controlled Study in Cranioplasty Reconstruction
Multicenter Prospective Controlled Study in Cranioplasty Reconstruction
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients which need cranial reconstruction,
- Cranioplasty reconstruction by autologous bone, hidroxyapatite or polymethylmethacrylate,
- Patients of both sex in age range between 14 and 75 years old,
- Craniolacuniae size > 25 cm2 ,
- Patients affected by complex pathologies or fracture or infection of a previous implant.
- Elegibility to CustomBone Service™ Cranial treatment will respect the product leaflet instructions.
- Each investigator will respect his own medical centre internal inclusion criteria to cranial reconstruction.
Exclusion Criteria:
- Patients affected by important emocoagulation pathologies,
- Patients affected by mellitus diabetes,
- Patients affected by autoimmune pathology,
- Patients unable to intend,
- Patients affected by immunodepression.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hydroxyapatite Cranioplasty
patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis
|
customized hydroxyapatite cranial prosthesis
Other Names:
|
polymethylmethacrylate
patient underwent to cranioplasty reconstruction with polymethylmethacrylate prosthesis
|
customized hydroxyapatite cranial prosthesis
Other Names:
|
autologous bone
patients underwent to cranioplasty reconstruction by autologous bone repositioning
|
customized hydroxyapatite cranial prosthesis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 360 day after surgery
|
incidence of adverse event (infection, reabsorption, mobilization, fractures, dislocation) after surgical treatment
|
360 day after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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;
|
90, 180, 360, 720 days after the surgery
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Franco Servadei, Prof. MD, Maggiore Hospital Parma
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEU02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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