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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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01528553 - Stapling Versus 8plate for Correction of Genu Valgus N/A
Recruiting NCT05763901 - IMU-based Assessment of Motor Control in a Population of Young Subjects With Paramorphisms and Dysmorphisms N/A