rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
Recruitment status was: Not yet recruiting
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
Intervention Model: Parallel Assignment
Masking: None (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 ]
- Infection [ Time Frame: up to one year ]
- Edema [ Time Frame: up to one year ]
- cancer [ Time Frame: up to one year ]
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||January 2016 (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