Bioactive Glass Composite Implants in Cranial Bone Recons... | NCT01202838

Studies
Bioactive Glass Composite Implants in Cranial Bone Reconstruction

NCT01202838

Sponsor

Turku University Hospital

Status

Unknown status

Last Update Posted

Sep 16, 2010Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Bone Substitutes

Interventions

Composite Implant

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jul 26, 2010

First Submission Date that Met QC Criteria

Sep 14, 2010

First Posted Date

Sep 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2010

Last Update Posted Date

Sep 16, 2010Estimated

Name	Class
University of Turku	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to study composites of bioactive glass and methylmetacrylate with glass fibre reinforcement in cranial bone defect reconstruction.

Detailed Description

Traditional skull and facial bone reconstructions with hard tissues have a long history with good clinical outcomes. However, they have certain disadvantages. The benefits of synthetic materials are the avoidance of donor-site morbidity and scars, but also shorter hospitalization time, lower expenses and known composition. Custom-made skull bone implant can produced based on patients clinical need utilizing rapid prototyping technologies. This will result in very high accuracy of the form of the skull defect.

Polymethylmetacrylate (PMMA) is one of the most widely used alloplastic material in surgery. Bioactive glass S53P4 (BAG) particles have been used in various clinical indications. BAG was added to composite implant of PMMA with glass fibre reinforcement to enhance bone ingrowth to implant, and to utilize BAG's antimicrobial effects. Ten patients cranial defects are treated with composite implants.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Composite Implant		Subject receiving composite implant	Device: Composite Implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Composite Implant	Device	Subjects receiving composite implants	Composite Implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical success	Clinical success is evaluated using clinical and radiographic examination, and blood count.	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with cranial bone defect larger than 4x4 cm after trauma or tumor surgery
patient signs written study consent

Exclusion Criteria:

patient is unlikely to adhere to study procedures
patient has a disease or condition that in the opinion of investigator is contraindicating participation
patient is participating another medical device or drug trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients of Turku university hospital needing cranial bone defect reconstruction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matti J Peltola, MD, PhD, DDS	Contact	+35823130000		matti.peltola@tyks.fi
Kalle MJ Aitasalo, MD, PhD, DDS	Contact	+35823130000		kalle.aitasalo@tyks.fi

Overall Officials

Name	Affiliation	Role
Matti J Peltola, MD, PhD, DDS	Turku University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turku University Hospital	Recruiting	Turku		20521	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18634960	Background	Peltola MJ, Aitasalo KM, Aho AJ, Tirri T, Suonpaa JT. Long-term microscopic and tissue analytical findings for 2 frontal sinus obliteration materials. J Oral Maxillofac Surg. 2008 Aug;66(8):1699-707. doi: 10.1016/j.joms.2007.11.020. No abstract available.
16823870	Background	Peltola M, Aitasalo K, Suonpaa J, Varpula M, Yli-Urpo A. Bioactive glass S53P4 in frontal sinus obliteration: a long-term clinical experience. Head Neck. 2006 Sep;28(9):834-41. doi: 10.1002/hed.20436.