Clinical Trial: Stapling Versus 8plate for Correction of Genu Valgus

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Stapling Versus 8plate for Correction of Genu Valgus. A Randomised Clinical Study

Brief Summary:

In children with excessive knock knees it may be necessary to use guided growth (small surgical procedure) so the child outgrows the condition before maturity. A new implant is on the market and the investigators compare this implant (8plate) with the old technique (staples) in a randomised setup.

The hypothesis is that the 8plate provides a faster correction rate and that this treatment is superior to stapling.


Detailed Summary: Correcting angulating deformities of the lower limb is a subject of major interest in paediatric orthopaedics. Epiphysiodesis is the technique by which unilateral bone growth is stopped. Traditionally this has been performed with staple technique. The 8-plate technique is new and advocated because it is believed to reduce the risk of premature closure of the growth plate compared to stapling. The benefit of the 8-plate technique has not yet been proven in experimental or randomised clinical studies.
Sponsor: University of Aarhus

Current Primary Outcome: Treatment time [ Time Frame: up to 104 weeks ]

Will be followed with repeated clinical examinations until correction of deformity.


Original Primary Outcome: Same as current

Current Secondary Outcome: Radiological correction [ Time Frame: up to 104 weeks ]

After correction of deformity.


Original Secondary Outcome: Same as current

Information By: University of Aarhus

Dates:
Date Received: January 20, 2012
Date Started: August 2009
Date Completion: August 2012
Last Updated: February 3, 2012
Last Verified: February 2012