An interventional study of 8plate and Staples (Richards, Smith & Nephew) in Deformity and Genu Valgus, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to participants aged 8 Years to 15 Years. Per ClinicalTrials.gov, last updated 2012-02-08.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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.
University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Old implant type
Device: Staples (Richards, Smith & Nephew)
New implant type
Device: 8plate
12 mm or 16 mm plate. 24 mm or 36 mm screw
Also known as: 8plate system
Staples (3 on each side)
Also known as: Richards staples, Smith & Nephew
Treatment time
Will be followed with repeated clinical examinations until correction of deformity.
Time frame: up to 104 weeks
Radiological correction
After correction of deformity.
Time frame: up to 104 weeks
This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Genu Valgum
University of Aarhus