NCT01528553

Stapling Versus 8plate for Correction of Genu Valgus

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Deformity
• Genu Valgus

Interventions

Type	Name	Description
DEVICE	8plate	12 mm or 16 mm plate. 24 mm or 36 mm screw
DEVICE	Staples (Richards, Smith & Nephew)	Staples (3 on each side)

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-02-08
• Last updated: 2012-02-08

Locations

1 site across 1 country: Denmark