Overview

This trial is active, not recruiting.

Condition hallux valgus
Treatment bongener
Phase phase 4
Sponsor Severance Hospital
Start date April 2013
End date August 2014
Trial size 30 participants
Trial identifier NCT02388438, CGBIOB1306, SS-13-Bongener

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Applied demineralized bone matrix when investigator conduct hallux valgus surgery.
bongener

Primary Outcomes

Measure
days to union from applied demineralized bone matrix
time frame: up to 12months

Secondary Outcomes

Measure
Complete fusion rate after applied medical device.
time frame: up to 12months
Complete correction rate after applied medical device.
time frame: up to 12months
Change from baseline AOFAS(American Orthopaedic Foot and Ankle Society) at 12 months.
time frame: change form baseline at 12months

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

Official title Efficiency and Safety of Demineralized Bone Matrix in the Proximal Opening Wedge Osteotomy for Hallux Valgus Deformity
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Severance Hospital.