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A randomized, single-blind, parallel positive control, multi-center clinical study to evaluate the safety and effectiveness of the biodegradable zinc alloy maxillofacial internal fixation system for the treatment of maxillofacial bone fractures

A randomized, single-blind, parallel positive control, multi-center clinical study to evaluate the safety and effectiveness of the biodegradable zinc alloy maxillofacial internal fixation system for the treatment of maxillofacial bone fractures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051050
Enrollment
Unknown
Registered
2021-09-10
Start date
2021-10-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Maxillofacial fractures

Interventions

experimental group:Degradable zinc alloy maxillofacial internal fixation system
Control group:Cranio-Maxillofacial System

Sponsors

The Third Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 60 years(including 18 and 60 years), regardless of gender; 2. There is a clear history of trauma, clinical manifestations of maxillofacial bone fractures, clear fracture images can be seen on imaging examination, and a diagnosis of maxillofacial bone fractures; the treatment method is open reduction and internal fixation; 3. Volunteer to participate in this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with maxillofacial fractures with severe soft tissue defects and wound infections; 2. Maxillofacial fractures with multiple injuries; 3. Those with local bone defect; 4. The investigator judges the benign and malignant tumor patients who cannot be selected and those who have received radiotherapy; 5. Those who have a history of osteoporosis and corresponding medication history through X-ray examination; 6. Severe liver, kidney, brain, cardiovascular, respiratory, endocrine and other system diseases who cannot withstand surgery; 7. Mental diseases, infectious diseases, drug abusers; 8. Systemic use of corticosteroid hormones (such as prednisone, dexamethasone, hydrocortisone, etc.); 9. Those who have participated in or are participating in other clinical trials within 3 months before the start of this trial; 10. People with a history of metal allergy; 11. Pregnant and lactating women, and women who plan to become pregnant within 3 years; 12. Those who have used degradable implantable devices; 13. Other circumstances judged by the researcher to be unsuitable for selection.

Design outcomes

Primary

MeasureTime frame
Product efficiency;

Secondary

MeasureTime frame
Wound healing;Recovery of occlusal relationship;Openness;

Countries

China

Contacts

Public ContactTian Lei

The Third Affiliated Hospital of Air Force Military Medical University

tianleison@163.com+86 138 9194 9360

Outcome results

None listed

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