SHOX Gene With Short Stature Clinical Trial
Official title:
Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients
| Verified date | April 2011 |
| Source | Bilen, Fikri Erkal, M.D. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Turkey:Institute for Drugs and Medicine Devices |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | March 2011 |
| Est. primary completion date | March 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Years to 11 Years |
| Eligibility |
Inclusion Criteria: - Achondroplasia, first lengthening period Exclusion Criteria: - Previous lengthening |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Istanbul Medical School | Istanbul |
| Lead Sponsor | Collaborator |
|---|---|
| Bilen, Fikri Erkal, M.D. |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Minimum 2 year follow-up | No |