Stapling Versus 8plate for Correction of Genu Valgus
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|ClinicalTrials.gov Identifier: NCT01528553|
Recruitment Status : Unknown
Verified February 2012 by University of Aarhus.
Recruitment status was: Active, not recruiting
First Posted : February 8, 2012
Last Update Posted : February 8, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Deformity Genu Valgus||Device: 8plate Device: Staples (Richards, Smith & Nephew)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Stapling Versus 8plate for Correction of Genu Valgus. A Randomised Clinical Study|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||August 2012|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528553
|Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Bjarne Møller-Madsen, Professor||Aarhus University Hospital|