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

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ClinicalTrials.gov Identifier: NCT02609074
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborators:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai 6th People's Hospital
Shanghai Zhongshan Hospital
Information provided by (Responsible Party):
Yuan Yuan, East China University of Science and Technology

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).


Condition or disease Intervention/treatment Phase
Bone Fracture Procedure: Minimally invasive internal fixation surgeries Device: CPC/rhBMP-2 micro-scaffolds Device: CPC paste Phase 4

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration
Study Start Date : March 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: 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.

Procedure: Minimally invasive internal fixation surgeries
Device: CPC/rhBMP-2 micro-scaffolds
Active Comparator: 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.

Procedure: Minimally invasive internal fixation surgeries
Device: CPC paste



Primary Outcome Measures :
  1. X-ray [ Time Frame: Pre-operation; 1, 2, 3, 4, 6, 8, 12, 18 and 24 months post-operation. ]
    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.

  2. Clinical examination [ Time Frame: 1 week post-operation ]
    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.


Secondary Outcome Measures :
  1. Function scoring - IOWA knee score [ Time Frame: 1, 2, 3, 4, 6, 8 and 12 months post-operation. ]
    The functional recovery was recorded at each follow-up time point using IOWA knee score in cases of tibial plateau fractures. The IOWA knee score is a questionnaire and clinical-examination-based evaluation of the function of the knee. The knee score is a five- category measurement, which includes activities of daily living, freedom from pain, gait, aid dependence, deformity and range of movement. The scores are grouped into excellent (90 to 100), good (80 to 89), fair (70 to 79) and poor (under 70) categories.

  2. Function scoring - IOWA ankle score [ Time Frame: 1, 2, 3, 4, 6, 8 and 12 months post-operation. ]
    The functional recovery was recorded at each follow-up time point using IOWA ankle score in cases of calcaneal fractures. The IOWA ankle score is a questionnaire and clinical-examination-based evaluation of the function of the ankle. The ankle score is a four-category measurement of function, freedom from pain, gait and range of movement. The scores are grouped into excellent (90 to 100), good (80 to 89), fair (70 to 79) and poor (under 70) categories.

  3. Function scoring - NEER shoulder score [ Time Frame: 1, 2, 3, 4, 6, 8 and 12 months post-operation. ]
    The functional recovery was recorded at each follow-up time point using Neer shoulder score in cases of proximal humeral fractures. Neer shoulder score has three parts: scoring of pain during the previous week by patients (verbal rating scale); clinical testing of function (muscle strength, reaching ability, and stability) and active range of motion; and an anatomical or radiological evaluation. The scores are grouped into excellent (90 to 100), good (80 to 89), fair (70 to 79) and poor (under 70) categories.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609074


Sponsors and Collaborators
East China University of Science and Technology
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai 6th People's Hospital
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Changsheng Liu, Ph.D. Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology
Principal Investigator: 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

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Responsible Party: Yuan Yuan, Professor, East China University of Science and Technology
ClinicalTrials.gov Identifier: NCT02609074    
Other Study ID Numbers: CFDA No.(2013):3460199
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Yuan Yuan, East China University of Science and Technology:
bone substitute
CPC
rhBMP-2
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries