Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity

NCT ID: NCT02388438

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-12-31

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.

Conditions

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Hallux Valgus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Demineralized bone matrix

Applied demineralized bone matrix when investigator conduct hallux valgus surgery.

Group Type EXPERIMENTAL

Bongener

Intervention Type DEVICE

Interventions

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Bongener

Intervention Type DEVICE

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Woojin Choi

Orthopedic part

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CGBIOB1306

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SS-13-Bongener

Identifier Type: -

Identifier Source: org_study_id

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