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Controlled Study in Cranioplasty Reconstruction

NCT01641523 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2015-08-19

No results posted yet for this study

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 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.

Conditions

  • Cerebral Decompression Injury
  • Cranioplasty

Interventions

DEVICE

CustomBone Service

customized hydroxyapatite cranial prosthesis

Sponsors & Collaborators

  • Fin-Ceramica Faenza Spa

    collaborator INDUSTRY

  • Azienda Ospedaliero-Universitaria di Parma

    lead OTHER

Principal Investigators

  • Franco Servadei, Prof. MD · Maggiore Hospital Parma

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-01-31
Completion
2011-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01641523 on ClinicalTrials.gov