Clinical Study of Bioceramic Materials in Bone Defect Repair
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Quality of life (SF-36)
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Commercial bone implant product Group
Bone repair products in the market such as artificial bones and allogeneic bones.
Intervention: Commercial bone implant product Group (Device)
Mirco-structured Bioceramic Group
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.
Intervention: Mirco-structured Bioceramic Group (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported