Controlled Study in Cranioplasty Reconstruction - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Plastic and Cosmetic Surgery

U.S. FDA Resources

Further study details as provided by Fin-Ceramica Faenza Spa:

Primary Outcome Measures:

Safety [ Time Frame: 360 day after surgery ] [ Designated as safety issue: Yes ]
incidence of adverse event (infection, reabsorption, mobilization, fractures, dislocation) after surgical treatment

Secondary Outcome Measures:

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 cranioplasty autologous bone opercula
polymethylmethacrylate 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

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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

consecutive patients,in different italian centres, requiring cranioplasty

Criteria

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 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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641523

Sponsors and Collaborators

Fin-Ceramica Faenza Spa

Investigators


Study Director:	Franco Servadei, Prof. MD	Maggiore Hospital Parma

More Information

No publications provided


Responsible Party:	Fin-Ceramica Faenza Spa
ClinicalTrials.gov Identifier:	NCT01641523 History of Changes
Other Study ID Numbers:	NEU02
Study First Received:	July 5, 2012
Last Updated:	July 12, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by Fin-Ceramica Faenza Spa:


Cranioplasty prosthesis Hydroxyapatite PolyMethylMethacrylate Autologous Bone

Additional relevant MeSH terms:


Polymethyl Methacrylate Antimutagenic Agents Cardiovascular Agents Pharmacologic Actions	Physiological Effects of Drugs Protective Agents Therapeutic Uses Vasodilator Agents

ClinicalTrials.gov processed this record on March 03, 2015