Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity

Phase 4

• Conditions: Hallux Valgus
• Interventions: Device: Bongener

• Registration Number: NCT02388438
• Lead Sponsor: Severance Hospital

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2014-08
• Status Verified: 2015-03
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-09
• Last Update Submitted: 2015-03-09
• Study First Posted: 2015-03-17
• Last Update Posted: 2015-03-17
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Demineralized bone matrix	Bongener	Applied demineralized bone matrix when investigator conduct hallux valgus surgery.

Primary Outcome Measures

Name	Time	Method
days to union from applied demineralized bone matrix	up to 12months	Examine the days from applied medical device to union.

Secondary Outcome Measures

Name	Time	Method
Complete fusion rate after applied medical device.	up to 12months	Examine the fusion rate of osteotomy site and evaluate fusion rate according to definition of protocol with every visit.
Complete correction rate after applied medical device.	up to 12months	Examine the corrected degree of hallux valgus and evaluate correction rate according to definition of protocol with every visit
Change from baseline AOFAS(American Orthopaedic Foot and Ankle Society) at 12 months.	change form baseline at 12months	Evaluate the AOFAS with every visit. Compared the AOFAS score with baseline AOFAS score.