Leg Length Discrepancy Clinical Trial
BACKGROUND: Distraction osteogenesis, the gradual lengthening of bones, is performed in
order to equalize leg length discrepancy and correct skeletal deformities or to achieve
greater height in short stature people. The femur and tibia are the bones most frequently
lengthened. The surgery is currently performed at Hadassah Medical Center routinely by the
pediatric orthopedic team utilizing a variety of external fixation devices.
The procedure involves application of an external fixation device to the bone, creation of
an osteotomy and gradual, controlled distraction of the bone fragments On the last week of
the distraction phase and every month thereafter, patients will be provided with a monthly
supply of gastrolith calcium in a sealed container (65 capsules of 500 mg each, provided by
Amorphical). Starting on the first day of the last week of the distraction phase, during the
entire consolidation phase until the external fixator is removed; adults will orally consume
two (2) 500 mg capsules a day (total of 1 gr of gastrolith calcium). Children will be given
25 mg calcium per kg body weight up to the daily adult dose of 1000mg .
| Status | Recruiting |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Years to 30 Years |
| Eligibility |
Inclusion Criteria: 1. Males and females 2. Ages 4-30 years old. Exclusion Criteria: 1. Product Allergy 2. Refusal to participate the study. 3. Metabolic Disorders |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Medical Organizaton | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization | Amorfical |
Israel,
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