Stapling Versus 8plate for Correction of Genu Valgus. A Randomised Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Aarhus
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Treatment time
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 8 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Idiopathic genu valgus
- •At least one year of remaining growth
Exclusion Criteria
- •Unilateral conditions
Outcomes
Primary Outcomes
Treatment time
Time Frame: up to 104 weeks
Will be followed with repeated clinical examinations until correction of deformity.
Secondary Outcomes
- Radiological correction(up to 104 weeks)