Stapling Versus 8plate for Correction of Genu Valgus

NCT ID: NCT01528553

Last Updated: 2012-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Deformity Genu Valgus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Staples

Old implant type

Group Type ACTIVE_COMPARATOR

Staples (Richards, Smith & Nephew)

Intervention Type DEVICE

Staples (3 on each side)

8plate

New implant type

Group Type ACTIVE_COMPARATOR

8plate

Intervention Type DEVICE

12 mm or 16 mm plate. 24 mm or 36 mm screw

Interventions

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8plate

12 mm or 16 mm plate. 24 mm or 36 mm screw

Intervention Type DEVICE

Staples (Richards, Smith & Nephew)

Staples (3 on each side)

Intervention Type DEVICE

Other Intervention Names

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8plate system Richards staples, Smith & Nephew

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unilateral conditions
Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bjarne Møller-Madsen, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 17414005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21983939 (View on PubMed)

Related Links

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http://dpor.dk/

Research Group Page

http://www.auh.dk/

Hospital Webpage

Other Identifiers

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VEK 20080179

Identifier Type: -

Identifier Source: org_study_id

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