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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02609074
Enrollment
81
Registered
2015-11-20
Start date
2013-03-31
Completion date
2015-10-31
Last updated
2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Fracture

Keywords

bone substitute, CPC, rhBMP-2

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).

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).

Interventions

PROCEDUREMinimally invasive internal fixation surgeries
DEVICECPC/rhBMP-2 micro-scaffolds
DEVICECPC paste

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
CollaboratorOTHER
Shanghai 6th People's Hospital
CollaboratorOTHER
Shanghai Zhongshan Hospital
CollaboratorOTHER
East China University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
X-rayPre-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.
Clinical examination1 week post-operationThe 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

MeasureTime frameDescription
Function scoring - IOWA knee score1, 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.
Function scoring - IOWA ankle score1, 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.
Function scoring - NEER shoulder score1, 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026