Controlled Study in Cranioplasty Reconstruction

NCT01641523 | Completed DMC

• 1 other identifier: NEU02
• Study Type: observational
• Target: 91
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cranioplasty prosthesis; Hydroxyapatite; PolyMethylMethacrylate; Autologous Bone

Outcome Measures

Primary Outcomes (1)

• Safety

  incidence of adverse event (infection, reabsorption, mobilization, fractures, dislocation) after surgical treatment

  360 day after surgery

Secondary Outcomes (1)

• Efficacy

  90, 180, 360, 720 days after the surgery

Study Arms (3)

Hydroxyapatite Cranioplasty

patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis

Device: CustomBone Service

polymethylmethacrylate

patient underwent to cranioplasty reconstruction with polymethylmethacrylate prosthesis

Device: CustomBone Service

autologous bone

patients underwent to cranioplasty reconstruction by autologous bone repositioning

Device: CustomBone Service

Interventions

CustomBone Service DEVICE

customized hydroxyapatite cranial prosthesis

Also known as: polymethylmethacrylate cranioplasty, autologous bone opercula

Hydroxyapatite Cranioplasty; autologous bone; polymethylmethacrylate

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patients,in different italian centres, requiring cranioplasty

You may qualify if:

• 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.

You may not qualify if:

• Patients affected by important emocoagulation pathologies,
• Patients affected by mellitus diabetes,
• Patients affected by autoimmune pathology,
• Patients unable to intend,
• Patients affected by immunodepression.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead
• Fin-Ceramica Faenza Spa: collaborator

Study Officials

• Franco Servadei, Prof. MD

  Maggiore Hospital Parma

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Franco Servadei, Prof. MD

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 16, 2012
• Study Start: January 1, 2007
• Primary Completion: January 1, 2007
• Study Completion: September 1, 2011
• Last Updated: August 19, 2015

Record last verified: 2015-08