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Clinical Trials/NCT01528553
NCT01528553
Unknown
Not Applicable

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

University of Aarhus1 site in 1 country20 target enrollmentAugust 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deformity
Sponsor
University of Aarhus
Enrollment
20
Locations
1
Primary Endpoint
Treatment time
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
August 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Unilateral conditions

Outcomes

Primary Outcomes

Treatment time

Time Frame: up to 104 weeks

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

Secondary Outcomes

  • Radiological correction(up to 104 weeks)

Study Sites (1)

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