Pseudarthrosis Clinical Trial
Official title:
rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
When there is a bone defect, bone transport is used to bridge the defect. Frequently, the
bone in the docking site (where the transported bone comes together) doesn't heal.
The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing,
in order to find new techniques to treat non-union of long bones.
The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous
bone grafting in stimulating bone healing in the docking site.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | April 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Patients treated with bone transport (Ilizarov technique) and have non-union of the docking site, which is characterized by absence of bridging callus after two months of compression in the docking site. Exclusion Criteria: - Allergy for inductos - active growth, - malignancy - infection - PAD - pathological fracture |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Universitaire Ziekenhuizen Leuven |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Bone healing in the docking site | up to 4 months | No | |
| Secondary | Infection | up to one year | Yes | |
| Secondary | Edema | up to one year | Yes | |
| Secondary | cancer | up to one year | Yes |
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