Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02388438

Acronym

DBM

Enrollment

Registered

2015-03-17

Start date

2013-04-30

Completion date

2015-12-31

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus

Keywords

demineralized bone matrix

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.

Interventions

DEVICEBongener

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Other

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026