NCT01641354

Brief Summary

Knock knees or genu valgus necessitates in some children corrective surgery with partial closure of the growth plate at level of the knee.

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
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 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

May 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

3.2 years

First QC Date

June 7, 2010

Last Update Submit

July 12, 2012

Conditions

Genu Valgus

Keywords

Hemiepiphysiodesis

Outcome Measures

Primary Outcomes (1)

  • Treatment time

    up to 3 years

Secondary Outcomes (1)

  • Pain score post operatively

    up to 3 years

Interventions

HemiepiphysiodesisPROCEDURE

Partial closure of growth plate to correct deformity

Eligibility Criteria

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

You may qualify if:

  • genu valgus
  • remaining growth

You may not qualify if:

  • systemic disease
  • unilateral disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Gottliebsen M, Rahbek O, Hvid I, Davidsen M, Hellfritzsch MB, Moller-Madsen B. Hemiepiphysiodesis: similar treatment time for tension-band plating and for stapling: a randomized clinical trial on guided growth for idiopathic genu valgum. Acta Orthop. 2013 Apr;84(2):202-6. doi: 10.3109/17453674.2013.782526. Epub 2013 Mar 14.

    PMID: 23485073DERIVED

MeSH Terms

Conditions

Genu Valgum

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD-student

Study Record Dates

First Submitted

June 7, 2010

First Posted

July 16, 2012

Study Start

May 1, 2009

Primary Completion

July 1, 2012

Study Completion

June 1, 2013

Last Updated

July 16, 2012

Record last verified: 2012-07

Locations

DK(1)