Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration
NCT ID: NCT02609074
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
81 participants
INTERVENTIONAL
2013-03-31
2015-10-31
Brief Summary
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Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been considered as the most perspective among all bone substitutes, yet little progress of its clinical translation has been made. The concept of "micro-scaffolds" was proposed in this study to provide a trajectory to its clinical translation.
Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further applied as an easy-to-operate filler for bone regeneration in a pilot clinical study. Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2 microffolds or traditional CPC paste (control group).
Detailed Description
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Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been considered as the most perspective among all bone substitutes, yet little progress of its clinical translation has been made. The concept of "micro-scaffolds" was proposed in this study to provide a trajectory to its clinical translation.
Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further applied as an easy-to-operate filler for bone regeneration in a pilot clinical study. Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2 microffolds or traditional CPC paste (control group).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CPC/rhBMP-2
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.
Minimally invasive internal fixation surgeries
CPC/rhBMP-2 micro-scaffolds
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 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.
Minimally invasive internal fixation surgeries
CPC paste
Interventions
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Minimally invasive internal fixation surgeries
CPC/rhBMP-2 micro-scaffolds
CPC paste
Eligibility Criteria
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Inclusion Criteria
2. Tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a similar level of severity.
3. An understanding of the rehabilitation protocol and willing to follow it.
4. An agreement to postoperative visits and tests.
5. Signed an informed subject consent form.
Exclusion Criteria
16 Years
70 Years
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Shanghai 6th People's Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
East China University of Science and Technology
OTHER
Responsible Party
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Yuan Yuan
Professor
Principal Investigators
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Changsheng Liu, Ph.D.
Role: STUDY_CHAIR
Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology
Yuan Yuan, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology
Jinwu Wang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ninth People's Hospital of Shanghai Jiao Tong University
Other Identifiers
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CFDA No.(2013):3460199
Identifier Type: -
Identifier Source: org_study_id