Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration

East China University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Bone Fracture

Treatments: Device: CPC paste; Device: CPC/rhBMP-2 micro-scaffolds; Procedure: Minimally invasive internal fixation surgeries

Study type: Interventional

Funder types: Other

Identifiers

NCT02609074

CFDA No.(2013):3460199

Details and patient eligibility

About

Objective: The investigators initiated a pilot clinical study to test safety and preliminary efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and rehabilitation protocols.

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).

Full description

Objective: The investigators initiated a pilot clinical study to test safety and preliminary efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and rehabilitation protocols.

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).

Enrollment: 81 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 16~70 years.
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

CPC/rhBMP-2

Experimental group

Description:

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.

Treatment:

Device: CPC/rhBMP-2 micro-scaffolds

Procedure: Minimally invasive internal fixation surgeries

CPC

Active Comparator group

Description:

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.

Treatment:

Device: CPC paste

Procedure: Minimally invasive internal fixation surgeries