Stapling Versus 8plate for Correction of Genu Valgus
Recruitment status was: Active, not recruiting
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.
|Deformity Genu Valgus||Device: 8plate Device: Staples (Richards, Smith & Nephew)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Care Provider)
Primary Purpose: Treatment
|Official Title:||Stapling Versus 8plate for Correction of Genu Valgus. A Randomised Clinical Study|
- Treatment time [ Time Frame: up to 104 weeks ]Will be followed with repeated clinical examinations until correction of deformity.
- Radiological correction [ Time Frame: up to 104 weeks ]After correction of deformity.
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Staples
Old implant type
Device: Staples (Richards, Smith & Nephew)
Staples (3 on each side)
Other Name: Richards staples, Smith & Nephew
Active Comparator: 8plate
New implant type
12 mm or 16 mm plate. 24 mm or 36 mm screw
Other Name: 8plate system
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528553
|Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Bjarne Møller-Madsen, Professor||Aarhus University Hospital|