rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
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|ClinicalTrials.gov Identifier: NCT01756144|
Recruitment Status : Unknown
Verified May 2015 by Dr Jan Vanderstappen, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Not yet recruiting
First Posted : December 25, 2012
Last Update Posted : May 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pseudarthrosis||Device: rhBMP-2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||April 2016|
Active Comparator: Autologous bone grafting
autologous bone of the iliac crest
Inductos, recombinant human bone morphogenetic protein
- 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 ]