Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients

April 1, 2011 updated by: Bilen, Fikri Erkal, M.D.
The purpose of this study is to determine whether lengthening of both the tibiae and femora in achondroplastic patients is safe and provides reproducible outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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

  • Turkey
      • Istanbul, Turkey, 34390
        • Istanbul Medical School

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

3 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Achondroplasia, first lengthening period

Exclusion Criteria:

  • Previous lengthening

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Achondroplasia lengthening
Procedure: Lengthening over nail
External fixator is used to lengthen either the femur or the tibia over an intramedullary nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paley's functional scoring system
Time Frame: Minimum 2 year follow-up
Paley's functional scoring system evaluates the results after lengthening or deformity correction procedures: residual limb length discrepancy, any brace or other aid usage, joint contracture, pain, soft tissue dystrophism
Minimum 2 year follow-up

Collaborators and Investigators

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

Sponsor

Bilen, Fikri Erkal, M.D.

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

April 1, 2002

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (Estimate)

April 4, 2011

Study Record Updates

Last Update Posted (Estimate)

April 4, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Akondroplazi - Bilen

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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