Stapling Versus 8plate for Correction of Genu Valgus

University of Aarhus

Status: Unknown

Conditions: Deformity; Genu Valgus

Treatments: Device: Staples (Richards, Smith & Nephew); Device: 8plate

Study type: Interventional

Funder types: Other

Identifiers

NCT01528553

VEK 20080179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic genu valgus
• At least one year of remaining growth

Exclusion criteria

• Unilateral conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Staples

Active Comparator group

Description:

Old implant type

Treatment:

Device: Staples (Richards, Smith & Nephew)

8plate

Active Comparator group

Description:

New implant type

Treatment:

Device: 8plate