Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity (DBM)

Yonsei University

Status and phase

Unknown

Phase 4

Conditions

Hallux Valgus

Treatments

Device: Bongener

Study type

Interventional

Funder types

Other

Identifiers

NCT02388438

SS-13-Bongener

CGBIOB1306 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No 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