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

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

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

Study Overview

• Status: Unknown
• Conditions: Hallux Valgus
• Intervention / Treatment: Device: Bongener

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Demineralized bone matrix; Applied demineralized bone matrix when investigator conduct hallux valgus surgery.	Device: Bongener

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Severance Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: demineralized bone matrix
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: SS-13-Bongener; CGBIOB1306 (Other Grant/Funding Number: CGBIO CO., LTD.)