Efficacy of Bioceramic Materials for Bone Defects Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Commercial bone implant product Group, Mirco-structured Bioceramic Group.
- Who it may be relevant to
- Registry conditions: Bone Lesion, Cartilage Degeneration, Osteo Arthritis Knee, Bone Fracture. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study of Bioceramic Materials in Bone Defect Repair
Overview
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
- Device Commercial bone implant product Group
Commercial bone implant product Group with a smooth surface （without particular microstructures）. - Device Mirco-structured Bioceramic Group
β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on.
Primary outcome measures
- Quality of life (SF-36) [Time frame: 12 months]
- Level of bone healing [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Nanjing First Hospital — Nanjing
Identifiers
NCT: NCT06249906 · KY20231109-04