Cranioplasty Clinical Trial
Official title:
Multicenter Prospective Controlled Study in Cranioplasty Reconstruction
Verified date | August 2015 |
Source | Azienda Ospedaliero-Universitaria di Parma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
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 Serviceā¢ 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.
Status | Completed |
Enrollment | 91 |
Est. completion date | September 2011 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years to 75 Years |
Eligibility |
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 Serviceā¢ 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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria di Parma | Fin-Ceramica Faenza Spa |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | incidence of adverse event (infection, reabsorption, mobilization, fractures, dislocation) after surgical treatment | 360 day after surgery | Yes |
Secondary | Efficacy | 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 | No |
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