NCT02388438

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2013

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

March 4, 2015

Last Update Submit

March 9, 2015

Conditions

Hallux Valgus

Keywords

demineralized bone matrix

Outcome Measures

Primary Outcomes (1)

  • days to union from applied demineralized bone matrix

    Examine the days from applied medical device to union.

    up to 12months

Secondary Outcomes (3)

  • 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

Other Outcomes (1)

  • Adverse events

    up to 12months

Study Arms (1)

Demineralized bone matrix

EXPERIMENTAL

Applied demineralized bone matrix when investigator conduct hallux valgus surgery.

Device: Bongener

Interventions

BongenerDEVICE
Demineralized bone matrix

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic part

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 17, 2015

Study Start

April 1, 2013

Primary Completion

August 1, 2014

Study Completion

December 1, 2015

Last Updated

March 17, 2015

Record last verified: 2015-03