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Evaluate the forestry, multi -center, random, and parallel clinical trials of magnesium alloy hollow for orthopedics fractures

Evaluate the forestry, multi -center, random, and parallel clinical trials of magnesium alloy hollow for orthopedics fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085675
Enrollment
Unknown
Registered
2024-06-14
Start date
2024-03-20
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

For orthopedic surgery fractures are fixed, you need to do hand, feet and limb fractures, bone discomfort, and bone interception fixed parts

Interventions

Test group:Use the magnesium alloy hollow bone screw produced by Suzhou Yingno Medical Technology Co., Ltd.
Control group:Use the hollow nail system produced by Cindez Co., Ltd.

Sponsors

Beijing Jishui Tan Hospital, Beijing, Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18 ? age ?65 -year -old adult subjects; 2. There is an orthopedic surgery indicator that needs to be treated with fracture internal fixed surgery; 3. Injury to a subject who is less than or equal to 21 days; 4. The subjects who voluntarily participate in this experiment and sign the consent of informed consent;

Exclusion criteria

Exclusion criteria: 1. Local infection of the whole body or surgery site; 2. Insufficient bone volume of implanted parts, subjects who cannot fix the implant; 3. A subject of hypermiamia; 4. A subject of pathological fractures of the surgical site; 5. A subject with nerve injury in the surgical site; 6. Fractive fractures are subject to osteomyelitis and osteoidum chamber syndrome; 7. The surgical site is the subject of the palm finger and the backbone of the foot -toe toe bones. 8. The surgical site is a fixed subject with long backbone fractures of the limbs. 9. A subject of metabolic bone disease (except for the elderly osteoporosis); 10. A subject with malignant tumors; 11. A subject with severe craniocerebral brain and organ injury; 12. Severe hearts, liver, kidney, lung, blood system and other diseases who cannot tolerate surgery; 13. Use sedative hypnotic pills, non -sterite anti -inflammatory drugs (more than 3 months in a row); 14. Women who are pregnant, breastfeeding, and participating in this trial within 1 year of pregnancy plan; 15. A subject with cognitive dysfunction such as dementia and delirium; 16. A subject who participated in other clinical trials within 3 months;

Design outcomes

Primary

MeasureTime frame
Excellent surgical treatment effect;

Secondary

MeasureTime frame
Excellent surgical treatment effect;Instrument operation performance evaluation;Wound -level healing rate evaluation;Evaluation of the degree of degradation of screws;

Countries

China

Contacts

Public ContactXieyuan Jiang/Maoqi Gong

Beijing Jishui Tan Hospital, Beijing, Affiliated to Capital Medical University

xingchen@intkmed.com+86 12345678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026