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

NCT02609074 | Completed Phase 4

• 1 other identifier: CFDA No.(2013):3460199
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Bone Fracture

Keywords

bone substitute; CPC; rhBMP-2

Outcome Measures

Primary Outcomes (2)

• X-ray

  X-ray radiography at different time intervals after implantation was employed to observe the osseointegration of the implanted microffolds to host bone and the degradation of the material.

  Pre-operation; 1, 2, 3, 4, 6, 8, 12, 18 and 24 months post-operation.

• Clinical examination

  The assessment was based on clinical examination. After the CPC implantation, all patients were observed according to the following indexes: allergic or toxic reactions, rash or high fever.

  1 week post-operation

Secondary Outcomes (3)

• Function scoring - IOWA knee score

  1, 2, 3, 4, 6, 8 and 12 months post-operation.

• Function scoring - IOWA ankle score

  1, 2, 3, 4, 6, 8 and 12 months post-operation.

• Function scoring - NEER shoulder score

  1, 2, 3, 4, 6, 8 and 12 months post-operation.

Study Arms (2)

CPC/rhBMP-2

EXPERIMENTAL

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.

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

CPC

ACTIVE COMPARATOR

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.

Procedure: Minimally invasive internal fixation surgeries; Device: CPC paste

Interventions

Minimally invasive internal fixation surgeries PROCEDURE

CPC; CPC/rhBMP-2

CPC/rhBMP-2 micro-scaffolds DEVICE

CPC/rhBMP-2

CPC paste DEVICE

CPC

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• East China University of Science and Technology: lead
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• Shanghai 6th People's Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Changsheng Liu, Ph.D.

  Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology

  STUDY CHAIR

• Yuan Yuan, Ph.D.

  Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Jinwu Wang, Ph.D.

  Ninth People's Hospital of Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: March 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 20, 2015

Record last verified: 2015-11