Ignite Creation Date:
2025-12-18 @ 8:15 AM
Ignite Modification Date:
2025-12-23 @ 9:39 PM
Study NCT ID:
NCT05758623
Status:
None
Last Update Posted:
2023-03-07 00:00:00
First Post:
2023-02-13 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mg-containing Biodegradable Polymer Bone Repair Material
Sponsor:
None
Organization:
Study Overview
Official Title:
Mg-containing Biodegradable Polymer Bone Repair Material
Status:
None
Status Verified Date:
2023-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: