Back to resultsSimultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients
Primary Purpose
SHOX Gene With Short Stature
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lengthening over nail
Sponsored by
About this trial
This is an interventional treatment trial for SHOX Gene With Short Stature focused on measuring Lengthening
Eligibility Criteria
Inclusion Criteria:
- Achondroplasia, first lengthening period
Exclusion Criteria:
- Previous lengthening
Sites / Locations
- Istanbul Medical School
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Achondroplasia lengthening
Arm Description
Outcomes
Primary Outcome Measures
Paley's functional scoring system
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01328418
Brief Title
Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients
Official Title
Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bilen, Fikri Erkal, M.D.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SHOX Gene With Short Stature
Keywords
Lengthening
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Achondroplasia lengthening
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Lengthening over nail
Intervention Description
External fixator is used to lengthen either the femur or the tibia over an intramedullary nail
Primary Outcome Measure Information:
Title
Paley's functional scoring system
Description
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
Time Frame
Minimum 2 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Achondroplasia, first lengthening period
Exclusion Criteria:
Previous lengthening
Facility Information:
Facility Name
Istanbul Medical School
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients
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