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Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328418
First Posted: April 4, 2011
Last Update Posted: April 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bilen, Fikri Erkal, M.D.
  Purpose
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.

Condition Intervention
SHOX Gene With Short Stature Procedure: Lengthening over nail

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients

Resource links provided by NLM:


Further study details as provided by Bilen, Fikri Erkal, M.D.:

Primary Outcome Measures:
  • 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


Enrollment: 22
Study Start Date: April 2002
Study Completion Date: March 2011
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Achondroplasia lengthening Procedure: Lengthening over nail
External fixator is used to lengthen either the femur or the tibia over an intramedullary nail

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Achondroplasia, first lengthening period

Exclusion Criteria:

  • Previous lengthening
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328418


Locations
Turkey
Istanbul Medical School
Istanbul, Turkey, 34390
Sponsors and Collaborators
Bilen, Fikri Erkal, M.D.
  More Information

Responsible Party: Mehmet Kocaoglu, MD, Professor, Istanbul Medical School
ClinicalTrials.gov Identifier: NCT01328418     History of Changes
Other Study ID Numbers: Akondroplazi - Bilen
First Submitted: April 1, 2011
First Posted: April 4, 2011
Last Update Posted: April 4, 2011
Last Verified: April 2011

Keywords provided by Bilen, Fikri Erkal, M.D.:
Lengthening

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases