Stapling Versus 8plate for Correction of Genu Valgus

Not Applicable

• Conditions: Deformity; Genu Valgus
• Interventions: Device: Staples (Richards, Smith & Nephew); Device: 8plate

• Registration Number: NCT01528553
• Lead Sponsor: University of Aarhus

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2012-01-20
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-03
• Last Update Submitted: 2012-02-03
• Study First Posted: 2012-02-08
• Last Update Posted: 2012-02-08
• Primary Completion: 2012-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Idiopathic genu valgus
• At least one year of remaining growth

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Exclusion Criteria

• Unilateral conditions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Staples	Staples (Richards, Smith & Nephew)	Old implant type
8plate	8plate	New implant type

Primary Outcome Measures

Name	Time	Method
Treatment time	up to 104 weeks	Will be followed with repeated clinical examinations until correction of deformity.

Secondary Outcome Measures

Name	Time	Method
Radiological correction	up to 104 weeks	After correction of deformity.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark