Calcaneal Neck Lengthening Osteotomy in Children With Artificial Bone Graft

Flatfeet Clinical Trial

Official title:

Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyapatite / β- Tricalcium Phosphate Bone Substitute

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01618812
• Other study ID #: M-20090162
• 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

• Flatfeet
• Flatfoot
• Pes Plano Valgus

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