Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity

Severance Hospital30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hallux Valgus

Interventions

BongenerDEVICE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

days to union from applied demineralized bone matrix

Examine the days from applied medical device to union.

Time frame: up to 12months

Secondary Outcomes

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.

Time frame: up to 12months

Complete correction rate after applied medical device.

Examine the corrected degree of hallux valgus and evaluate correction rate according to definition of protocol with every visit

Time frame: up to 12months

Change from baseline AOFAS(American Orthopaedic Foot and Ankle Society) at 12 months.

Evaluate the AOFAS with every visit. Compared the AOFAS score with baseline AOFAS score.

Time frame: change form baseline at 12months

Data from ClinicalTrials.gov

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