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Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients

This study has been completed.
Information provided by:
Bilen, Fikri Erkal, M.D. Identifier:
First received: April 1, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
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: 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


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

Inclusion Criteria:

  • Achondroplasia, first lengthening period

Exclusion Criteria:

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

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 Identifier: NCT01328418     History of Changes
Other Study ID Numbers: Akondroplazi - Bilen
Study First Received: April 1, 2011
Last Updated: April 1, 2011

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

Additional relevant MeSH terms:
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases processed this record on May 24, 2017