Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02388438
NCT02388438
Unknown
Phase 4

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

Severance Hospital0 sites30 target enrollmentApril 2013
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHallux Valgus

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Hallux Valgus
Sponsor
Severance Hospital
Enrollment
30
Primary Endpoint
days to union from applied demineralized bone matrix
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
December 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Woojin Choi

Orthopedic part

Severance Hospital

Eligibility Criteria

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)

Similar Trials

Recruiting
Not Applicable
se of Demineralized bone matrix to increase healing capacity in management of Atypical femoral fractureAtypical femoral fractureDemineralized bone matrixDelay unionAtypical femoral fractureDemineralized bone matrixDelay union
TCTR20171028001Faculty of Medicine, Ramathibodi hospital28
Completed
Not Applicable
Demineralised bone matrix (DBM) as an alternative for autogenous bone graft in high tibial valgus opening wedge osteotomy (HTO) for symptomatic medial compartmental knee osteoarthritis
ISRCTN76261748Erasmus Medical Centre (The Netherlands)80
Completed
Not Applicable
Demineralized bone matrix (DBM putty) versus iliac crest bone graft for anterior single-level interbody fusion in thoracolumbar fractures. A prospective randomized controlled pilot trialS22.0S32.0Fracture of thoracic vertebraFracture of lumbar vertebra
DRKS00021632Synthes, Inc., Oberdorf, Schweiz30
Completed
Not Applicable
Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine FusionDegenerative ChangesStenosisSpondylosis
NCT02018445SeaSpine, Inc.36
Completed
Phase 4
Efficacy of DBM on Fractures of the Shinbone (Tibia)Closed FractureOpen Fracture
NCT00299052Emory University16