The Combined Effect of Mesenchymal Stem Cell, HA-CaSO4,BMP-2, and Implant in Inducing The Healing of Critical-Sized Bone Defect
Recruitment status was: Not yet recruiting
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.
Drug: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
- RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union [ Time Frame: Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years ] [ Designated as safety issue: No ]plain radiograps will be taken to determine whether the bone has healed.
- Visual analog scale as the measure of clinical union [ Time Frame: Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years ] [ Designated as safety issue: No ]We will measure VAS (grade 0-10) to determine the clinical union
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
|Drug: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725698
|University of Indonesia, National University of Singapore|
|Jakarta, Singapore, Indonesia, Singapore, Indonesia, 14430|