Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences | OTHER |
| Chinese University of Hong Kong | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
The subjects of this study are patients with non-load-bearing bone defects of the extremities who need bone grafting surgery. The patients was treated with bone graft using magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd.. Three follow-up visits were performed at the 12th, 24th and 36th weeks after bone grafting, the clinical role for bone will be assessed.
The subjects of this study are patients with non-load-bearing bone defects of the extremities who need bone grafting surgery. The subjects were randomly divided into experimental group and control group. The experimental group was treated with bone graft using magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd., while the control group was treated with bone graft β- Tricalcium phosphate bioceramics were used for bone transplantation. Three follow-up visits were performed at the 12th, 24th and 36th weeks after bone grafting. It is estimated that 176 cases will be recruited in total, and 135 cases have been recruited since April 2021. This product can be degraded and absorbed in vivo, and it can promote the formation of new bone.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| magnesium containing biodegradable polymer bone repair material | Placebo Comparator | The experimental group was treated with magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd. |
|
| β- Tricalcium phosphate bioceramics | Placebo Comparator | Control group application β- Tricalcium phosphate bioceramics for treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device | Device | The experimental group was treated with magnesium containing biodegradable polymer bone repair material produced by Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd. Control group application β- Tricalcium phosphate bioceramics for treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone graft fusion rate | When Mg-containing degradable polymer bone repair material is used to repair non-load-bearing bone defects of limbs, the main effective evaluation index is bone graft fusion rate at 24 weeks after operation | 24 weeks after standard operation |
| Measure | Description | Time Frame |
|---|---|---|
| to evaluate the bone graft fusion rate | to evaluate the bone graft fusion rate at 12 and 36 weeks after operation | 12 and 36 weeks after operation |
| Improvement level of SF-36 scale and satisfaction of device operation |
Not provided
Inclusion Criteria:
Age ≥ 18 years old and ≤ 75 years old, regardless of gender;
Bone defect exists in one of the following anatomical positions, and bone grafting is required:
Upper limb bones: humerus, ulna, radius, metacarpus, carpus, phalanges;
Lower limb bones: femur, tibia, fibula, calcaneus, navicular bone, wedge bone, cuboid bone, metatarsal bone, talus and phalanges;
The maximum diameter of the expected or actual three-dimensional bone defect is ≥ 0.5cm and ≤ 6cm, and the defect is only one;
The bone defect site is expected to be fixed with non-degradable internal fixation system during operation;
Subjects or their legal representatives can understand the purpose of the study and show sufficient compliance with the study protocol and sign the informed consent form.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Zhang, MD. | Contact | +86 15817386880 | 0755 23729746 | zhangming1307@163.com |
| Yuxiao Meng, MD. | Contact | 18776931278 | yuxiaomeng0712@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuxiao Lai, Professor | Ext:+86 755 86392581 Email:Yx.Lai@siat.ac.cn Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences | Principal Investigator |
| Ling Qin, Professor | Ext:+86-755-86392258 Email:lingqin@cuhk.edu.hk The Chinese University of Hong Kong |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd | Recruiting | Shenzhen | Guangdong | 518105 | China |
Not provided
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Improvement level of SF-36 scale and satisfaction of instrument operation at 36 weeks after operation
| at 36 weeks after operation |
| Study Director |