Trials / Unknown
UnknownNCT05758623
Mg-containing Biodegradable Polymer Bone Repair Material
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- Sponsor
- Shenzhen Zhongke Jingcheng Medical Technology Co., Ltd · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2023-04-30
- Completion
- 2024-03-31
- First posted
- 2023-03-07
- Last updated
- 2023-03-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05758623. Inclusion in this directory is not an endorsement.