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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Commercial bone implant product Group | Active Comparator | Bone repair products in the market such as artificial bones and allogeneic bones. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercial bone implant product Group | Device | Commercial bone implant product Group with a smooth surface (without particular microstructures). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Level of bone healing | X-ray, CT and MRI images would be used to evaluate the efficacy of bone healing. | 12 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain self-efficacy (PSEQ) | 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. | through study completion, about 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqiang Yao, phD | Contact | 15366155699 | yaoqingqiang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingqiang Yao, phD | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| Mirco-structured Bioceramic Group | Device | β-tri-Calcium phosphate with microstructures such as grooves, patterns and so on. |
|
| Incidence of nonunion |
A nonunion is an arrest in the fracture repair process. |
| through study completion, about 12 months |
| Incidence of infections | If any infections happen, the experiment would be stopped. | through study completion, about 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |