Long Bone Non-union Clinical Trial
Official title:
Effect of rhBMP-2 or rhBMP-7 on Long Bone Fractures and Non-unions.
Delayed fracture healing continues to cause significant patient morbidity and economic burden to society. Biological stimulation of acute fractures and non-unions includes application of rhBMP-2 and rhBMP-7. However, BMP use continues to be a matter of controversy as literature shows scarce evidence for treatment effectiveness. The aim of this study is to compare acute fractures and non-unions in the long bones humerus, femur and tibia with and without BMP treatment of acute fractures. Furthermore, the investigators want to identify complications and risk factors on union-rate and time to union.
Primary Objective: The primary objective is to assess time to union and union rate after rhBMP-2 and rhBMP-7 application at long bone fractures and non-unions. Secondary Objective(s): - Analysis of secondary complications - Analysis of risk factors Hypothesis and Statistical considerations and estimated enrollment: The investigators hypothesize that with the use of rhBMP-2 and rhBMP-7 there will be a faster timer to union and higher union rate compared to no-BMP. Outcomes will be assessed prospectively. This study is exploratory in nature. Therefore, there is no formal statistical hypothesis and no formal sample size calculation. Approximately 150 long-bone fractures and non-unions are expected. Data will be analyzed with the use of simple summary statistics. Depending on the volume and quality of the collected data, different statistical analyses will be applied. Exploratory analyses will be conducted to investigate relationships between the different treatment options and the outcomes. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01756326 -
Study on Autologous Osteoblastic Cells Implantation in Hypotrophic Non-Union Fractures
|
Phase 2/Phase 3 |