Stapling Versus 8plate for Correction of Genu Valgus

Deformity Clinical Trial

Official title:

Stapling Versus 8plate for Correction of Genu Valgus. A Randomised Clinical Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01528553
• Other study ID #: VEK 20080179
• Status: Active, not recruiting
• Phase: N/A
• First received: January 20, 2012
• Last updated: February 3, 2012
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: February 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

Inclusion Criteria:

• Idiopathic genu valgus

• At least one year of remaining growth

Exclusion Criteria:

• Unilateral conditions

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deformity
• Genu Valgum
• Genu Valgus

Intervention

Device:
• 8plate
12 mm or 16 mm plate. 24 mm or 36 mm screw
• Staples (Richards, Smith & Nephew)
Staples (3 on each side)

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Jelinek EM, Bittersohl B, Martiny F, Scharfstädt 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment time	Will be followed with repeated clinical examinations until correction of deformity.	up to 104 weeks	No
Secondary	Radiological correction	After correction of deformity.	up to 104 weeks	No

External Links

•   Hospital Webpage
•   Research Group Page