This trial is active, not recruiting.

Conditions deformity, genu valgus
Treatments 8plate, staples (richards, smith & nephew)
Sponsor University of Aarhus
Start date August 2009
End date August 2012
Trial size 20 participants
Trial identifier NCT01528553, VEK 20080179


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
(Active Comparator)
Old implant type
staples (richards, smith & nephew) Richards staples, Smith & Nephew
Staples (3 on each side)
(Active Comparator)
New implant type
8plate 8plate system
12 mm or 16 mm plate. 24 mm or 36 mm screw

Primary Outcomes

Treatment time
time frame: up to 104 weeks

Secondary Outcomes

Radiological correction
time frame: up to 104 weeks

Eligibility Criteria

Male or female participants from 8 years up to 15 years old.

Inclusion Criteria: - Idiopathic genu valgus - At least one year of remaining growth Exclusion Criteria: - Unilateral conditions

Additional Information

Official title Stapling Versus 8plate for Correction of Genu Valgus. A Randomised Clinical Study
Principal investigator Bjarne Møller-Madsen, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by University of Aarhus.