Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity

Study Overview
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Brief Summary
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This study evaluates the demineralized bone matrix in Hallux valgus.

Detailed Description
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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.

Official Title
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Efficiency and Safety of Demineralized Bone Matrix in the Proximal Opening Wedge Osteotomy for Hallux Valgus Deformity

Conditions
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Hallux Valgus

Intervention / Treatment
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* Device: Bongener


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Demineralized bone matrix<br>Applied demineralized bone matrix when investigator conduct hallux valgus surgery. | Device: Bongener<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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. | Examine the corrected degree of hallux valgus and evaluate correction rate according to definition of protocol with every visit | 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. | change form baseline at 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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demineralized bone matrix