Union Clinical Trial
| Verified date | November 2012 |
| Source | Indonesia University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Indonesia: Ethics Committee |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 5 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 17 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - subjects with critical size defect of bone Exclusion Criteria: - subjects with patological fracture caused by primary or secondary bone malignancy, imunological deficit, active hepatitis or those who's under immunosuppresant therapy or other therapeutic modality that can interferes with bone healing. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Indonesia | University of Indonesia, National University of Singapore | Jakarta, Singapore | Indonesia, Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Indonesia University |
Indonesia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |