- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01528553
Stapling Versus 8plate for Correction of Genu Valgus
Stapling Versus 8plate for Correction of Genu Valgus. A Randomised Clinical Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Aarhus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Idiopathic genu valgus
- At least one year of remaining growth
Exclusion Criteria:
- Unilateral conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Staples
Old implant type
|
Staples (3 on each side)
Other Names:
|
Active Comparator: 8plate
New implant type
|
12 mm or 16 mm plate.
24 mm or 36 mm screw
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment time
Time Frame: up to 104 weeks
|
Will be followed with repeated clinical examinations until correction of deformity.
|
up to 104 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological correction
Time Frame: up to 104 weeks
|
After correction of deformity.
|
up to 104 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bjarne Møller-Madsen, Professor, Aarhus University Hospital
Publications and helpful links
General Publications
- Stevens PM. Guided growth for angular correction: a preliminary series using a tension band plate. J Pediatr Orthop. 2007 Apr-May;27(3):253-9. doi: 10.1097/BPO.0b013e31803433a1.
- Jelinek EM, Bittersohl B, Martiny F, Scharfstadt A, Krauspe R, Westhoff B. The 8-plate versus physeal stapling for temporary hemiepiphyseodesis correcting genu valgum and genu varum: a retrospective analysis of thirty five patients. Int Orthop. 2012 Mar;36(3):599-605. doi: 10.1007/s00264-011-1369-5. Epub 2011 Oct 9.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VEK 20080179
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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