Hallux ValgusPhase 4DBMNCT02388438
Demineralized Bone Matrix in Opening Wedge Osteotomy for Hallux Valgus Deformity
A Phase 4 study testing Bongener in people with Hallux Valgus, run by Severance Hospital.
Trial summary
This study evaluates the demineralized bone matrix in "Hallux valgus". Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Bongener
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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
About this study
Official title: Efficiency and Safety of Demineralized Bone Matrix in the Proximal Opening Wedge Osteotomy for Hallux Valgus Deformity
This study evaluates the demineralized bone matrix in "Hallux valgus".
Read the 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.
- Conditions
- Hallux Valgus
- Being tested
- Bongener
- Keywords
- demineralized bone matrix
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BongenerDevice
| Study group | Role | What they receive |
|---|---|---|
| Demineralized bone matrix | Experimental | Applied demineralized bone matrix when investigator conduct hallux valgus surgery. Receives: Device: Bongener |
What is being measured
The primary outcome is the main question the study is designed to answer.
days to union from applied demineralized bone matrix
Examine the days from applied medical device to union.
Measured: up to 12months
Secondary outcomes (3)
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.
Measured: up to 12months
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
Measured: up to 12months
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.
Measured: change form baseline at 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startApr 2013
- Primary completionAug 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woojin Choi, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388438
- Sponsor's protocol ID
- SS-13-Bongener
- Other IDs
- CGBIOB1306
- Acronym
- DBM
- Status last verified
- Mar 2015
- First submitted
- 4 Mar 2015
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety of Demineralized Bone Matrix in the Proximal Opening Wedge Osteotomy for Hallux Valgus Deformity
- ClinicalTrials.gov ID
- NCT02388438
- Acronym / sponsor ID
- DBM / SS-13-Bongener
- Conditions
- Hallux Valgus
- Keywords
- demineralized bone matrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Demineralized bone matrix | Experimental | Device: BongenerApplied demineralized bone matrix when investigator conduct hallux valgus surgery. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (5 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bongener | Device | Demineralized bone matrix |
Primary outcome
days to union from applied demineralized bone matrix
Time frame: up to 12months
Examine the days from applied medical device to union.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bongener in people with Hallux Valgus, run by Severance Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
days to union from applied demineralized bone matrix (time frame: up to 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.