Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity

Hallux Valgus Clinical Trial

— DBM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02388438
• Other study ID #: SS-13-Bongener
• Secondary ID: CGBIOB1306
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 4, 2015
• Last updated: March 9, 2015
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Device:
• Bongener

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Evaluate adverse event after applied medical device. Examine adverse every visit.	up to 12months	Yes
Primary	days to union from applied demineralized bone matrix	Examine the days from applied medical device to union.	up to 12months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No