NCT01645267

Brief Summary

In this foot deformity (plano valgus) surgery may be indicated. The deformity is corrected with an osteotomy at the heelbone. In most cases bone graft material has to be obtained from the iliac crest to support the osteotomy. In the planned study a group of children will be operated with an artificial bone graft material and thus avoiding the need harvesting of bone graft at the iliac crest.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

July 12, 2012

Last Update Submit

July 19, 2012

Conditions

Flatfoot

Outcome Measures

Primary Outcomes (1)

  • Healing of osteotomy

    up to 1 year

Study Arms (1)

Osteotomy

EXPERIMENTAL

Using hydroxyapatite bone graft material

Procedure: Hydroxyapatite

Interventions

HydroxyapatitePROCEDURE

Use of artifical bonegraft material

Osteotomy

Eligibility Criteria

Age8 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Flatfoot condition needing surgery

You may not qualify if:

  • Traumatic conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Flatfoot

Interventions

Durapatite

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

HydroxyapatitesApatitesCalcium PhosphatesPhosphatesPhosphoric AcidsPhosphorus AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsCalcium CompoundsMineralsPhosphorus Compounds

Study Officials

  • Martin Gottliebsen, PhD-student

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-student

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 20, 2012

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2013

Last Updated

July 20, 2012

Record last verified: 2012-07