NCT01528553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

3 years

First QC Date

January 20, 2012

Last Update Submit

February 3, 2012

Conditions

DeformityGenu Valgus

Keywords

genu valguslower limbpaediatricepiphysiodesis

Outcome Measures

Primary Outcomes (1)

  • Treatment time

    Will be followed with repeated clinical examinations until correction of deformity.

    up to 104 weeks

Secondary Outcomes (1)

  • Radiological correction

    up to 104 weeks

Study Arms (2)

Staples

ACTIVE COMPARATOR

Old implant type

Device: Staples (Richards, Smith & Nephew)

8plate

ACTIVE COMPARATOR

New implant type

Device: 8plate

Interventions

8plateDEVICE

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

Also known as: 8plate system
8plate
Staples (Richards, Smith & Nephew)DEVICE

Staples (3 on each side)

Also known as: Richards staples, Smith & Nephew
Staples

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Unilateral conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 17414005BACKGROUND

  • 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.

    PMID: 21983939BACKGROUND

Related Links

MeSH Terms

Conditions

Congenital AbnormalitiesGenu Valgum

Interventions

Sutures

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Bjarne Møller-Madsen, Professor

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2012

First Posted

February 8, 2012

Study Start

August 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 8, 2012

Record last verified: 2012-02

Locations

DK(1)