NCT01618812

Brief Summary

In a group of children with severe and painful flatfeet lengthening procedures of calcaneus can be indicated. In this study the investigators use an artificial bone graft technique to avoid removing bone graft from the iliac crest.

Trial Health

43
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 all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

2.1 years

First QC Date

June 11, 2012

Last Update Submit

June 12, 2012

Conditions

Pes Plano ValgusFlatfeet

Keywords

Artificial bone graftHydroxyapatiteChildrenOsteotomyPes plano valgusFlatfeet

Outcome Measures

Primary Outcomes (1)

  • Healing of osteotomy

    Will be followed with repeated clinical examinations until healing

    104 weeks

Study Arms (1)

Pes plano valgus

Children with painful flatfeet

Procedure: Lateral lengthening osteotomy of calcaneus

Interventions

Lateral lengthening osteotomy of calcaneusPROCEDURE

Use of artificial bone graft

Also known as: Hydroxyapatite
Pes plano valgus

Eligibility Criteria

Age8 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

• children with planovalgus deformity referred to Dept. of Children's Orthopaedics, Dept of Orthopaedic Surgery E, Aarhus University Hospital from June 2009 until January 2012.

You may qualify if:

  • pain
  • gait disturbance

You may not qualify if:

  • post traumatic conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 13, 2012

Study Start

September 1, 2010

Primary Completion

October 1, 2012

Study Completion

April 1, 2013

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

DK(1)