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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01641523
Other study ID # NEU02
Secondary ID
Status Completed
Phase N/A
First received July 5, 2012
Last updated August 18, 2015
Start date January 2007
Est. completion date September 2011

Study information

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

Clinical Trial 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 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.


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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
CustomBone Service
customized hydroxyapatite cranial prosthesis

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria di Parma Fin-Ceramica Faenza Spa

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04111562 - Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects N/A
Recruiting NCT06097845 - Transcranial Ultrasound Via Sonolucent Cranioplasty N/A
Terminated NCT00923793 - Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty Phase 3
Enrolling by invitation NCT05362370 - Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness