Comparison of Two Surgical Techniques to Treat Knock Knees in Children

July 12, 2012 updated by: Martin Gottliebsen, Aarhus University Hospital

Reversible Hemiepiphysiodesis in Children - Stapling Versus Eight Plate

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: Genu valgus is a condition with malalignment of the lower extremity. Surgery may be indicated in severe cases and reversible hemiepiphysiodesis is often the treatment of choice in growing children. Partial closure can be obtained by stapling technique or with a new treatment called tension band plating.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • genu valgus
  • remaining growth

Exclusion Criteria:

  • systemic disease
  • unilateral disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment time
Time Frame: up to 3 years
up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain score post operatively
Time Frame: up to 3 years
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ANTICIPATED)

July 1, 2012

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

July 12, 2012

First Posted (ESTIMATE)

July 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 12, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20080179
  • J.nr. 2009-41-3248 (OTHER: Datatilsynet)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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