Reduction and fixation of bone flap after craniotomy
Conditions
Interventions
Experimental group:Use test group instruments
Control group:Use control group instrument
Sponsors
Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Bone flap reduction and fixation after neurosurgical craniotomy; 2. Male and female subjects, aged 18 years or older and younger than 70 years old; 3. When subjects are patients with simple intracranial space-occupying tumors such as aneurysms and meningiomas, they should not be accompanied by metastasis of other organic organs; 4. When the subject is a patient requiring bone flap fixation after skull trauma, there should be no potential infection; 5. The subjects and/or their families voluntarily sign the informed consent to participate in the trial, and can cooperate with the postoperative follow-up, and cannot participate in other clinical trials within 9 months.
Exclusion criteria
Exclusion criteria: 1. Patients who need to discard bone flap after neurosurgical craniotomy; 2. The subject is less than 18 years old; 3. The subjects had metastatic tumors or multiple intracranial lesions; 4. Patients with scalp local infection; 5. Subjects with underlying diseases such as diabetes, hypertension, and heart disease who are not suitable to participate in the experiment after comprehensive evaluation by the researcher; 6. Lactic acid material allergy; 7. People with mental illness; 8. Pregnant or breastfeeding women and women who plan to become pregnant within 6 months; 9. Patients who participated in other clinical trials within the last three months; 10. Patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After three-dimensional reconstruction of the cranial CT of the two groups of cases, the mean distances of the cranial fissures at the third and sixth months after the operation were measured and compared.; | — |
Secondary
| Measure | Time frame |
|---|---|
| After three-dimensional reconstruction of cranial CT in the two groups of cases, the mean distances of the cranial bone gaps at the 12th month after surgery were measured and compared.;The qualified rate of displacement distance of the fixed bone flap at 0-7 days, 6 weeks, 3 months, 6 months and 12 months after surgery was measured and compared between the two groups after skull CT 3D reconstruction; | — |
Countries
China
Contacts
Public ContactLi XueJun
Xiangya Hospital of Central South University
Outcome results
None listed