Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration
Bone Fracture
About this trial
This is an interventional treatment trial for Bone Fracture focused on measuring bone substitute, CPC, rhBMP-2
Eligibility Criteria
Inclusion Criteria:
- Age 16~70 years.
- Tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a similar level of severity.
- An understanding of the rehabilitation protocol and willing to follow it.
- An agreement to postoperative visits and tests.
- Signed an informed subject consent form.
Exclusion Criteria:
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Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CPC/rhBMP-2
CPC
All operations were done by doctors titled with associate chief physician or above. Procedures were performed under general anesthesia in a tertiary care medical center. A minimally invasive internal fixation method had been applied in the surgeries. In brief, the patients with fracture were treated by reduction of fracture first of all, the correction of displacement, and the angle of the deformity, and the use of metal implants were fixed, and the collapse of the cancellous bone was filled with CPC/rhBMP-2 microffolds (product of Shanghai Rebone Biomaterials Co., Ltd, following the manufacturer's instruction), which was compacted and prevented from filling material into the joint cavity.
All operations were done by doctors titled with associate chief physician or above. Procedures were performed under general anesthesia in a tertiary care medical center. A minimally invasive internal fixation method had been applied in the surgeries. In brief, the patients with fracture were treated by reduction of fracture first of all, the correction of displacement, and the angle of the deformity, and the use of metal implants were fixed, and the collapse of the cancellous bone was filled with CPC paste (product of Shanghai Rebone Biomaterials Co., Ltd, following the manufacturer's instruction), which was compacted and prevented from filling material into the joint cavity.