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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport|
- Bone healing in the docking site [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]
- Infection [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]
- Edema [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]
- cancer [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Autologous bone grafting
autologous bone of the iliac crest
Inductos, recombinant human bone morphogenetic protein