Demineralized Bone Matrix in Opening Wedge Osteotomy for... | NCT02388438

Studies
Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity

NCT02388438

Sponsor

Severance Hospital

Status

Unknown status

Last Update Posted

Mar 17, 2015Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Hallux Valgus

Interventions

Bongener

Countries

Not provided

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

ID	Type	Description	Link
CGBIOB1306	Other Grant/Funding Number	CGBIO CO., LTD.

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Aug 2014Actual

Completion Date

Dec 2015Estimated

First Submitted Date

Mar 4, 2015

First Submission Date that Met QC Criteria

Mar 9, 2015

First Posted Date

Mar 17, 2015Estimated

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

Mar 9, 2015

Last Update Posted Date

Mar 17, 2015Estimated

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

This study evaluates the demineralized bone matrix in "Hallux valgus".

Detailed Description

Demineralized bone matrix use for filling in the space removed bone in open wedge osteotomy and correction. The purpose this study is to test therapeutic benefits of demineralized bone matrix.

Investigator will recruit thirty patients. Total evaluation period will be 12 months. In this period, investigator will examine correction rate, fusion rate, functional test, adverse event.

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Demineralized bone matrix	Experimental	Applied demineralized bone matrix when investigator conduct hallux valgus surgery.	Device: Bongener

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bongener	Device		Demineralized bone matrix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
days to union from applied demineralized bone matrix	Examine the days from applied medical device to union.	up to 12months

Secondary Outcomes

Measure	Description	Time Frame
Complete fusion rate after applied medical device.	Examine the fusion rate of osteotomy site and evaluate fusion rate according to definition of protocol with every visit.	up to 12months
Complete correction rate after applied medical device.

Other Outcomes

Measure	Description	Time Frame
Adverse events	Evaluate adverse event after applied medical device. Examine adverse every visit.	up to 12months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) The patient ranging in age from 20 to 75 years
(2) Has to be operated over 5mm osteotomy for correcting hallux valgus.
(3) The patients who were able to comply with the research protocol.

Exclusion Criteria:

(1) Bursitis in metatarsal bones has affected surgery.
(2) Has rheumatism
(3) The patient who has clinical sign of infection on the operated site at pre-screening
(4) Patient who has failure of peripheral blood circulation caused by chronic disease and neurological symptoms
(5) In the opinion of investigator, the patient is not suitable to participate in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006215	Hallux Valgus

Ancestor Terms

ID	Term
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided