Cranial bone defect
Conditions
Interventions
Material repair group:Customized cranial repair materials for defect restoration
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Before the surgery, the subject or their guardian is willing and able to sign the informed consent form; 2. Participants aged 18 to 75 years (inclusive), regardless of gender; 3. Participants requiring (customized) cranial regeneration repair implant for cranial defects; 4. Participants with expected survival time more than 6 months; 5. No surgical contraindications based on preoperative routine laboratory tests and examinations; 6. Good compliance, willing and able to undergo follow-up observations as required.
Exclusion criteria
Exclusion criteria: 1. Obvious local or systemic severe infections, such as intracranial infections; 2. Any psychiatric, neuromuscular, or vascular conditions that may lead to unacceptable risks of fixation failure or complications during postoperative care; 3. Pregnancy; 4. Participants without sufficient soft tissue coverage at the surgical site; 5. Clear or suspected allergy to the polymer materials used in the product or to foreign bodies; 6. Severe consciousness disturbance, unstable intracranial pressure, or secondary hydrocephalus from cranial defects, as these conditions can cause intracranial pressure fluctuations and result in serious postoperative complications. However, cases evaluated by the investigator as insufficient to affect the safety and effectiveness of the surgery are excluded; 7. Systemic or metabolic diseases, except for participants with hypertension, diabetes, etc., who are under medication control within clinically acceptable ranges; 8. Participants with poor overall health status, such as coronary heart disease or hypertension, and considered unsuitable for surgery after evaluation by the anesthesia department; 9. Participants or family members unwilling or unable to follow postoperative therapy and/or rehabilitation protocol instructions; 10. Mental illness, drug abuse, or alcoholism, and participants unable to quit smoking during cranial defect healing; 11. Long-term use of medications that affect bone and soft tissue healing (e.g., chemotherapy drugs, corticosteroids, except methylprednisolone); use of growth factors, long-term use of sedative-hypnotics (more than 3 months), and long-term use of non-steroidal anti-inflammatory drugs (more than 3 months); 12. Other conditions deemed unsuitable for enrollment by the investigator; 13. Participants or family members who are mentally incapable or unable to understand the requirements of participating in the study; 14. Expected non-compliance; 15. Other comorbid conditions that limit participation in the study, prevent compliance with follow-up, or affect the scientific integrity of the research; 16. Refusal to sign the informed consent form; 17. Participants having been included in other clinical trials who have not reached the clinical trial endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant-induced new bone ingrowth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Rankin Scale (mRS);National Institutes of Health Stroke Scale (NIHSS);Glasgow Outcome Scale;Karnofsky Performance Status ;Montreal Cognitive Assessment;Minimum Mental State Examination; | — |
Countries
China
Contacts
Public ContactJianguo Xu
West China Hospital, Sichuan University
Outcome results
None listed