Controlled Study in Cranioplasty Reconstruction
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Purpose
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 | Intervention |
|---|---|
|
Cerebral Decompression Injury Cranioplasty |
Device: CustomBone Service |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Multicenter Prospective Controlled Study in Cranioplasty Reconstruction |
- Safety [ Time Frame: 360 day after surgery ] [ Designated as safety issue: Yes ]incidence of adverse event (infection, reabsorption, mobilization, fractures, dislocation) after surgical treatment
- Efficacy [ Time Frame: 90, 180, 360, 720 days after the surgery ] [ Designated as safety issue: No ]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;
| Enrollment: | 91 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Hydroxyapatite Cranioplasty
patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis
|
Device: CustomBone Service
customized hydroxyapatite cranial prosthesis
Other Names:
|
|
polymethylmethacrylate
patient underwent to cranioplasty reconstruction with polymethylmethacrylate prosthesis
|
Device: CustomBone Service
customized hydroxyapatite cranial prosthesis
Other Names:
|
|
autologous bone
patients underwent to cranioplasty reconstruction by autologous bone repositioning
|
Device: CustomBone Service
customized hydroxyapatite cranial prosthesis
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 14 Years to 75 Years (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01641523
| 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 |
| Study First Received: | July 5, 2012 |
| Last Updated: | August 18, 2015 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Azienda Ospedaliero-Universitaria di Parma:
|
Cranioplasty prosthesis Hydroxyapatite PolyMethylMethacrylate Autologous Bone |
Additional relevant MeSH terms:
|
Polymethyl Methacrylate Vasodilator Agents Antimutagenic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016