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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01618812
Other study ID # M-20090162
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 11, 2012
Last updated June 12, 2012
Start date September 2010
Est. completion date April 2013

Study information

Verified date June 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Observational

Clinical Trial 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.


Description:

The aim is to study the clinical and radiological effects of calcaneal lengthening with either autogen bonegraft or a HA-βTCP graft material in a group of children with planovalgus. The hypothesis is that it is possible to achieve a stabile osteotomy with HA-βTCP graft material equal to the use of autogen bonegraft thus avoiding the need to obtaining iliac crest graft material at growing children.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date April 2013
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 20 Years
Eligibility Inclusion Criteria:

- pain

- gait disturbance

Exclusion Criteria:

- post traumatic conditions

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Lateral lengthening osteotomy of calcaneus
Use of artificial bone graft

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healing of osteotomy Will be followed with repeated clinical examinations until healing 104 weeks No
See also
  Status Clinical Trial Phase
Completed NCT02055495 - Arthroereisis Versus Lateral Column Lengthening in the Treatment of Planovalgus Feet N/A