Cranio-maxillofacial bone reconstruction and internal fixation for trauma treatment
Conditions
Interventions
experimental instrument group VS control instrument group:Craniomaxillofacial bone repair, reconstruction and internal fixation of fractures
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 to 70 years; 2. Cranial or maxillofacial fractures are clearly diagnosed by CT, or the subject's skull or maxillofacial bone needs to be surgically repaired and reconstructed, and the investigator judges that it is suitable for internal fixation through the absorbable cranio-maxillofacial nail system; 3. The patients themselves and/or their authorized persons can understand the purpose of the research, and are willing to conduct follow-up evaluations in accordance with the requirements of the clinical research protocol, voluntarily participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The subject's skull or maxillofacial region has severe comminuted fractures; 2. The fracture time of the subject exceeds 7 days before the signing of the informed consent; 3. The subject has uncontrolled active infection locally or systemically; 4. Insufficient blood supply, insufficient bone quality or quantity at the fractured or broken end of the subject; 5. Subjects with decompression bone flaps; 6. The subject has a history of poor bone healing; 7. The subject has a history of cleft lip and palate or a history of cleft lip and palate surgery; 8. The subject has a history of craniofacial fracture or surgery at the same site; 9. Subjects with uncontrolled diabetes, hypertension, heart disease and other underlying diseases and comprehensive evaluation by the investigator are not suitable to participate in the trial; 10. The subject has a history of allergy to polylactic acid materials; 11. Subjects currently or in the past using corticosteroids systemically (such as prednisone, dexamethasone, hydrocortisone, etc.); 12. Subjects who have undergone head radiotherapy or have planned subsequent radiotherapy to the head; 13. Subjects with severe osteoporosis in the past or taking bisphosphonates within 6 months; 14. Subjects with a history of severe mental illness or obvious disturbance of consciousness who cannot cooperate; 15. The life expectancy of the subjects is less than 12 months; 16. The subject is currently pregnant or breastfeeding and planning to become pregnant during the study period; 17. The investigator judges that the subject's systemic or local conditions are not suitable for selection; 18. Subjects who have been in the past three months or who are participating in clinical trials of other drugs or devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Good incision healing;CT imaging results; | — |
Countries
China
Contacts
Public ContactXu Jianguo
West China Hospital of Sichuan University
Outcome results
None listed