Union Clinical Trial
This research is aimed to evaluate the combination of mesenchymal stem cell, HA-CaSO4,
BMP-2, and implant in treating critical-sized bone defect.
In the presence of critical-sized bone defect whose defect size is more than 2.5 cm, bone
will suffer a healing disturbance. In treating these conditions, the conventional method
were vascularised bone grafting and bone transport. But the existing methods of treatment
have many weaknesses Vascularized bone graft is a procedure with a high level of difficulty.
Hence not every orthopaedic surgeon were able to perform it. It also takes more operating
time and its failure rate is also quite high.
Meanwhile, external fixation which is applied with bone transport, was being often
complained by the patient in terms of cosmetic and psychologically.
According to diamond concept of bone healing, there are four main factors that influence the
bone healing. These factors are osteogenic factor (mesenchymal stem cell), osteconductive
factor (HA-CaSO4), osteoinductive factor (bone morphogenetic protein-2) and mechanical
component (implant). The potency of each component in fracture healing with/out bone defect
has been proved in many studies. The combined effect of these components is often studied as
well, but not in critical-sized bone defect.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment