Clinical Trial: Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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

Detailed Summary:

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.


Sponsor: Severance Hospital

Current Primary Outcome: days to union from applied demineralized bone matrix [ Time Frame: up to 12months ]

Examine the days from applied medical device to union.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complete fusion rate after applied medical device. [ Time Frame: up to 12months ]
    Examine the fusion rate of osteotomy site and evaluate fusion rate according to definition of protocol with every visit.
  • Complete correction rate after applied medical device. [ Time Frame: up to 12months ]
    Examine the corrected degree of hallux valgus and evaluate correction rate according to definition of protocol with every visit
  • Change from baseline AOFAS(American Orthopaedic Foot and Ankle Society) at 12 months. [ Time Frame: change form baseline at 12months ]
    Evaluate the AOFAS with every visit. Compared the AOFAS score with baseline AOFAS score.


Original Secondary Outcome: Same as current

Information By: Severance Hospital

Dates:
Date Received: March 4, 2015
Date Started: April 2013
Date Completion: December 2015
Last Updated: March 9, 2015
Last Verified: March 2015