Bone Fracture, Bone Injury, Bone Lesion, Bone Loss, Cartilage Degeneration, Osteo Arthritis Knee
Conditions
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.
Interventions
DEVICECommercial bone implant product Group
Commercial bone implant product Group with a smooth surface （without particular microstructures）.
DEVICEMirco-structured Bioceramic Group
β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who voluntarily take the test and sign the informed consent form; 2. Patients aged 18-65 years old with no history of allergies; 3. Patients able to communicate well with the investigator and follow the requirements of the entire trial.
Exclusion criteria
1. Patients who refuse to sign the informed consent form to participate in the trial; 2. Patients who are not in the age range of 18 to 65 years; 3. 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; 4. Patients in the acute phase of local or systemic bacterial infections; 5. Patients who cannot cooperate with the operation and evaluate the effect; 6. Other conditions that are considered inappropriate by the investigator to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of bone healing | 12 months | X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing. |
| Quality of life (SF-36) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain self-efficacy (PSEQ) | through study completion, about 12 months | The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire, developed in the 1980s by Michael Nicholas to assess the confidence people with ongoing pain have in performing activities while in pain. The PSEQ is applicable to all persisting pain presentations. |
| Incidence of nonunion | through study completion, about 12 months | A nonunion is an arrest in the fracture repair process. |
| Incidence of infections | through study completion, about 12 months | If any infections happen, the experiment would be stopped. |
Countries
China
Contacts
Primary ContactQingqiang Yao, phD
Outcome results
None listed