Bioactive Glass as Bone Graft Substitute in Operative Tre... | NCT00935870

Studies
Bioactive Glass as Bone Graft Substitute in Operative Treatment of Bone - a 10 Years Follow-up Study

NCT00935870

Sponsor

Vivoxid Ltd

Status

Completed

Last Update Posted

Jul 9, 2009Estimated

Enrollment

63Actual

Phase

Not provided

Conditions

Depressed Lateral Condyle Fracture
Benign Bone Tumour Cavity
Spinal Fusion

Interventions

Bioactive glass and/or autogenous bone

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

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jun 2008Actual

Completion Date

Feb 2009Actual

First Submitted Date

Jul 7, 2009

First Submission Date that Met QC Criteria

Jul 8, 2009

First Posted Date

Jul 9, 2009Estimated

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

Jul 8, 2009

Last Update Posted Date

Jul 9, 2009Estimated

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 main aim is to evaluate the long-term safety and bone healing in the operated area and to compare bioactive glass granules with autogenous bone as a filler material.

Detailed Description

Not provided

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

63Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
A	DEPRESSED LATERAL CONDYLE FRACTURE	Device: Bioactive glass and/or autogenous bone
B	BENIGN BONE TUMOR	Device: Bioactive glass and/or autogenous bone
C	SPINAL FUSION	Device: Bioactive glass and/or autogenous bone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bioactive glass and/or autogenous bone	Device	No intervention in the current study (10-year follow-up study)	A B C

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent obtained; Participation of previous clinical investigation with bioactive glass

Exclusion Criteria:

The subject is unlikely to adhere to study procedures
Concurrent disease or condition that in the opinion of the investigator is contraindicating participation
Simultaneous participation in another medical device or investigational drug trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects who participated to previous clinical investigations with bioactive glass about 10 years ago.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nina Lindfors, MD	Turku University Hospital/Helsinki University Hospital	Principal Investigator

Locations

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