Comparison of Two Surgical Techniques to Treat Knock Knees in Children

Genu Valgus Clinical Trial

Official title:

Reversible Hemiepiphysiodesis in Children - Stapling Versus Eight Plate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01641354
• Other study ID #: M-20080179
• Secondary ID: J.nr. 2009-41-32
• Status: Active, not recruiting
• Phase: N/A
• First received: June 7, 2010
• Last updated: July 12, 2012
• Start date: May 2009
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

Knock knees or genu valgus necessitates in some children corrective surgery with partial closure of the growth plate at level of the knee.

Description:

Background: Genu valgus is a condition with malalignment of the lower extremity. Surgery may be indicated in severe cases and reversible hemiepiphysiodesis is often the treatment of choice in growing children. Partial closure can be obtained by stapling technique or with a new treatment called tension band plating.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: June 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

Inclusion Criteria:

• genu valgus

• remaining growth

Exclusion Criteria:

• systemic disease

• unilateral disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genu Valgus

Intervention

Procedure:
• Hemiepiphysiodesis
Partial closure of growth plate to correct deformity

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment time		up to 3 years	No
Secondary	Pain score post operatively		up to 3 years	No