Actively Recruiting
Clinical Study of Bioceramic Materials in Bone Defect Repair
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2024-03-12
10
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to demonstrate how bioceramic implants affect the repair of human bone defects and to explore their use in bone defects, implantation, and fusion. The focus is on b2-tricalcium phosphate bioceramic implants, whose surface microstructure can be controlled to guide bone regeneration, promote bone restoration, speed up recovery, and improve bone quality, which has important clinical and social significance. Participants will receive either commercial bone implant products available in the market, such as artificial or allogeneic bones with smooth surfaces, or b2-tricalcium phosphate bioceramic implants featuring microstructures like grooves and patterns. These bioceramic materials have excellent compatibility with the body and properties that encourage bone growth and guidance, providing mechanical strength comparable or superior to human cancellous bone. During the study, participants will be monitored over 12 months to assess the quality of life using the SF-36 questionnaire and the level of bone healing. Researchers will evaluate how well the implants support bone repair and recovery. Participants must communicate well and follow study requirements, with safety and effectiveness carefully tracked throughout the trial period.
CONDITIONS
Brief Title
Efficacy of Bioceramic Materials for Bone Defects Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 unsuitable 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants receive either a commercial bone implant or a micro-structured bioceramic implant to repair bone defects.
1 visit (in-person implant procedure)
Duration - Up to 12 months
Participants are monitored to assess bone healing and recovery after the implant procedure.
Periodic visits over 12 months for assessments
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
Q
Qingqiang Yao, phD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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