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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stemcell | Experimental | Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union | plain radiograps will be taken to determine whether the bone has healed. | Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale as the measure of clinical union | We will measure VAS (grade 0-10) to determine the clinical union | Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Indonesia, National University of Singapore | Jakarta, Singapore | Indonesia, Singapore | 14430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30747273 | Derived | Dilogo IH, Phedy P, Kholinne E, Djaja YP, Fiolin J, Kusnadi Y, Yulisa ND. Autologous mesenchymal stem cell implantation, hydroxyapatite, bone morphogenetic protein-2, and internal fixation for treating critical-sized defects: a translational study. Int Orthop. 2019 Jun;43(6):1509-1519. doi: 10.1007/s00264-019-04307-z. Epub 2019 Feb 12. |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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