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Clinical Trials/NCT02388438
NCT02388438UnknownPhase 4

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

Severance Hospital0 sites30 target enrollmentStarted: April 2013Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Enrollment
30
Primary Endpoint
days to union from applied demineralized bone matrix
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

days to union from applied demineralized bone matrix

Time Frame: up to 12months

Examine the days from applied medical device to union.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Woojin Choi

Orthopedic part

Severance Hospital

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