Bone FracturePhase 4NCT02609074
Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration
A Phase 4 study testing Minimally invasive internal fixation surgeries, CPC/rhBMP-2 micro-scaffolds and CPC paste in people with Bone Fracture, run by East China University of Science and Technology.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Bone Fracture
- What is being tested?
- Minimally invasive internal fixation surgeries, CPC/rhBMP-2 micro-scaffolds and CPC paste
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Oct 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
About this study
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).
Read the 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).
- Conditions
- Bone Fracture
- Being tested
- Minimally invasive internal fixation surgeries, CPC/rhBMP-2 micro-scaffolds, CPC paste
- Keywords
- bone substitute, CPC, rhBMP-2
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive internal fixation surgeriesProcedure or surgery
CPC/rhBMP-2 micro-scaffoldsDevice
CPC pasteDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Minimally invasive internal fixation surgeries; Device: CPC paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week post-operation
Secondary outcomes (3)
Function scoring - IOWA knee score
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.
Measured: 1, 2, 3, 4, 6, 8 and 12 months post-operation.
Function scoring - IOWA ankle score
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.
Measured: 1, 2, 3, 4, 6, 8 and 12 months post-operation.
Function scoring - NEER shoulder score
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.
Measured: 1, 2, 3, 4, 6, 8 and 12 months post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- East China University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 6th People's Hospital, Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Yuan Yuan, East China University of Science and Technology
- Investigators
- Changsheng Liu, Ph.D., Study chair, Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and TechnologyYuan Yuan, Ph.D., Principal investigator, Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and TechnologyJinwu Wang, Ph.D., Principal investigator, Ninth People's Hospital of Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609074
- Sponsor's protocol ID
- CFDA No.(2013):3460199
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration
- ClinicalTrials.gov ID
- NCT02609074
- Acronym / sponsor ID
- CFDA No.(2013):3460199
- Conditions
- Bone Fracture
- Keywords
- bone substitute, CPC, rhBMP-2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- East China University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 6th People's Hospital, Shanghai Zhongshan Hospital
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPC/rhBMP-2 | Experimental | Procedure: Minimally invasive internal fixation surgeries, Device: CPC/rhBMP-2 micro-scaffoldsAll 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. |
| CPC | Active comparator | Procedure: Minimally invasive internal fixation surgeries, Device: CPC pasteAll 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. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive internal fixation surgeries | Procedure or surgery | CPC, CPC/rhBMP-2 |
| CPC/rhBMP-2 micro-scaffolds | Device | CPC/rhBMP-2 |
| CPC paste | Device | CPC |
Primary outcome
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.
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.
3 secondary outcomes
Function scoring - IOWA knee score
Time frame: 1, 2, 3, 4, 6, 8 and 12 months post-operation.
Function scoring - IOWA ankle score
Time frame: 1, 2, 3, 4, 6, 8 and 12 months post-operation.
Function scoring - NEER shoulder score
Time frame: 1, 2, 3, 4, 6, 8 and 12 months post-operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changsheng Liu, Ph.D. study chair
Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology
Yuan Yuan, Ph.D. principal investigator
Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology
Jinwu Wang, Ph.D. principal investigator
Ninth People's Hospital of Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minimally invasive internal fixation surgeries, CPC/rhBMP-2 micro-scaffolds and CPC paste in people with Bone Fracture, run by East China University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
X-ray (time frame: Pre-operation; 1, 2, 3, 4, 6, 8, 12, 18 and 24 months post-operation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.