Back to resultsDemineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity (DBM)
Primary Purpose
Hallux Valgus
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bongener
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus focused on measuring demineralized bone matrix
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Demineralized bone matrix
Arm Description
Applied demineralized bone matrix when investigator conduct hallux valgus surgery.
Outcomes
Primary Outcome Measures
days to union from applied demineralized bone matrix
Examine the days from applied medical device to union.
Secondary Outcome Measures
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.
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02388438
Brief Title
Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity
Acronym
DBM
Official Title
Efficiency and Safety of Demineralized Bone Matrix in the Proximal Opening Wedge Osteotomy for Hallux Valgus Deformity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Severance Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
demineralized bone matrix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Demineralized bone matrix
Arm Type
Experimental
Arm Description
Applied demineralized bone matrix when investigator conduct hallux valgus surgery.
Intervention Type
Device
Intervention Name(s)
Bongener
Primary Outcome Measure Information:
Title
days to union from applied demineralized bone matrix
Description
Examine the days from applied medical device to union.
Time Frame
up to 12months
Secondary Outcome Measure Information:
Title
Complete fusion rate after applied medical device.
Description
Examine the fusion rate of osteotomy site and evaluate fusion rate according to definition of protocol with every visit.
Time Frame
up to 12months
Title
Complete correction rate after applied medical device.
Description
Examine the corrected degree of hallux valgus and evaluate correction rate according to definition of protocol with every visit
Time Frame
up to 12months
Title
Change from baseline AOFAS(American Orthopaedic Foot and Ankle Society) at 12 months.
Description
Evaluate the AOFAS with every visit. Compared the AOFAS score with baseline AOFAS score.
Time Frame
change form baseline at 12months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Evaluate adverse event after applied medical device. Examine adverse every visit.
Time Frame
up to 12months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity
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