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Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients

This study has been completed.
Sponsor:
Information provided by:
Bilen, Fikri Erkal, M.D.
ClinicalTrials.gov Identifier:
NCT01328418
First received: April 1, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients

Resource links provided by NLM:

MedlinePlus related topics: Dwarfism
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Achondroplasia, first lengthening period

Exclusion Criteria:

  • Previous lengthening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328418

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

No publications provided

Responsible Party: Mehmet Kocaoglu, MD, Professor, Istanbul Medical School
ClinicalTrials.gov Identifier: NCT01328418     History of Changes
Other Study ID Numbers: Akondroplazi - Bilen
Study First Received: April 1, 2011
Last Updated: April 1, 2011
Health Authority: Turkey:Institute for Drugs and Medicine Devices

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

ClinicalTrials.gov processed this record on May 16, 2013