Deformity, Genu Valgus
Conditions
Keywords
genu valgus, lower limb, paediatric, epiphysiodesis
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.
Interventions
DEVICE8plate
12 mm or 16 mm plate. 24 mm or 36 mm screw
DEVICEStaples (Richards, Smith & Nephew)
Staples (3 on each side)
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Idiopathic genu valgus * At least one year of remaining growth
Exclusion criteria
* Unilateral conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment time | up to 104 weeks | Will be followed with repeated clinical examinations until correction of deformity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiological correction | up to 104 weeks | After correction of deformity. |
Countries
Denmark
Outcome results
None listed