Bone LesionNCT06249906
Efficacy of Bioceramic Materials for Bone Defects Repair
A study testing Commercial bone implant product Group and Mirco-structured Bioceramic Group in people with Bone Lesion and Cartilage Degeneration, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bone Lesion, Cartilage Degeneration, Osteo Arthritis Knee
- What is being tested?
- Commercial bone implant product Group and Mirco-structured Bioceramic Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who voluntarily take the test and sign the informed consent form;
- Patients aged 18-65 years old with no history of allergies;
- Patients able to communicate well with the investigator and follow the requirements of the entire trial.
Who cannot join
- Patients who refuse to sign the informed consent form to participate in the trial;
- Patients who are not in the age range of 18 to 65 years;
- Patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, Alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment;
- Patients in the acute phase of local or systemic bacterial infections;
- Patients who cannot cooperate with the operation and evaluate the effect;
- Other conditions that are considered inappropriate by the investigator to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210000
yufeng Wang, Master, +86 15895982668, wanyufeng2@126.com
About this study
Official title: Clinical Study of Bioceramic Materials in Bone Defect Repair
The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.
Read the detailed description
The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.
- Conditions
- Bone Lesion, Cartilage Degeneration, Osteo Arthritis Knee, Bone Fracture, Bone Injury, Bone Loss
- Being tested
- Commercial bone implant product Group, Mirco-structured Bioceramic Group
- Medical subject headings
- Fractures, Bone, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial bone implant product GroupDevice
Commercial bone implant product Group with a smooth surface （without particular microstructures）.
Mirco-structured Bioceramic GroupDevice
β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.
| Study group | Role | What they receive |
|---|---|---|
| Commercial bone implant product Group | Active comparator | Bone repair products in the market such as artificial bones and allogeneic bones. Receives: Device: Commercial bone implant product Group |
| Mirco-structured Bioceramic Group | Experimental | β-Tricalcium phosphate (β-TCP) is a material with excellent biocompatibility and osteoinduction and bone guidance properties, which can provide mechanical strength equal to or better than that of human cancellous bone. Receives: Device: Mirco-structured Bioceramic Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (SF-36)
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.
Measured: 12 months
Level of bone healing
X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start20 Feb 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LesionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qingqiang Yao, phD, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249906
- Sponsor's protocol ID
- KY20231109-04
- Status last verified
- Nov 2023
- First submitted
- 15 Dec 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Bioceramic Materials in Bone Defect Repair
- ClinicalTrials.gov ID
- NCT06249906
- Acronym / sponsor ID
- KY20231109-04
- Conditions
- Bone Lesion, Cartilage Degeneration, Osteo Arthritis Knee, Bone Fracture, Bone Injury, Bone Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Feb 2024 (actual)
- 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.
The purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.
Detailed description
The surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial bone implant product Group | Active comparator | Device: Commercial bone implant product GroupBone repair products in the market such as artificial bones and allogeneic bones. |
| Mirco-structured Bioceramic Group | Experimental | Device: Mirco-structured Bioceramic Groupβ-Tricalcium phosphate (β-TCP) is a material with excellent biocompatibility and osteoinduction and bone guidance properties, which can provide mechanical strength equal to or better than that of human cancellous bone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who voluntarily take the test and sign the informed consent form;
- Patients aged 18-65 years old with no history of allergies;
- Patients able to communicate well with the investigator and follow the requirements of the entire trial.
Key exclusion criteria (6 listed)
- Patients who refuse to sign the informed consent form to participate in the trial;
- Patients who are not in the age range of 18 to 65 years;
- Patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, Alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment;
- Patients in the acute phase of local or systemic bacterial infections;
- Patients who cannot cooperate with the operation and evaluate the effect;
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 |
|---|---|---|
| Commercial bone implant product GroupCommercial bone implant product Group with a smooth surface （without particular microstructures）. | Device | Commercial bone implant product Group |
| Mirco-structured Bioceramic Groupβ-tri-Calcium phosphate with microstructures such as grooves, patterns and so on. | Device | Mirco-structured Bioceramic Group |
Primary outcome
Quality of life (SF-36)
Time frame: 12 months
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used.
Level of bone healing
Time frame: 12 months
X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Qingqiang Yao, phD study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial bone implant product Group and Mirco-structured Bioceramic Group in people with Bone Lesion and Cartilage Degeneration, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingqiang Yao, phD (15366155699, yaoqingqiang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (SF-36) (time frame: 12 months). 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 12 Mar 2024.