Segmental defect of mandible
Conditions
Interventions
Traditional non-neuralized group:ignoring the neural innervation of the fibula flap, without nerve anastomosis
Simultaneous neuralized group:forming a sensory loop by anatomically dissecting the of the fibula flap and simultaneously anastomosing it with the recipient nerves of the mandible (inferior alveolar n
Sponsors
Shanghai Ninth People's Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 16 to 65 years, regardless of gender; 2. Patients with mandibular defects caused by tumors, inflammation, or trauma; 3. Segmental mandibular defects ranging from 4 cm to 17 cm; 4. Patients not diagnosed with osteoporosis, defined as having a T-score of >=-2.5 at any site (lumbar spine, femoral neck, or total hip) measured by DXA (dual-energy X-ray absorptiometry) and no history of fragility fractures; 5. Blood glucose can be controlled within the normal range (3.9 mmol/L or 70 mg/dL <= fasting plasma glucose <= 6.1 mmol/L or 110 mg/dL) after taking antidiabetic medications; 6. Patients who have not taken drugs that affect bone metabolism, such as bisphosphonates; 7. Patients who agree to sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Patients with advanced malignant tumors requiring postoperative radiochemotherapy; 2. Patients with poor general condition who cannot tolerate vascularized bone flap repair; 3. Pregnant women, lactating women, or women planning to become pregnant during the study period; 4. Patients with a known history of psychoactive substance abuse or drug use (including benzodiazepines, opioids, methamphetamine, etc.); 5. Patients with long-term (continuous >=3 months or cumulative >=3 months) systemic use of glucocorticoids (equivalent prednisone dose >=5 mg/day); 6. Patients with abnormal laboratory test results deemed clinically significant by the investigator: (1).Complete blood count: white blood cell count 3×ULN, serum creatinine >2×ULN; (3).Coagulation function: INR >1.8 or APTT >1.8×ULN (for patients not receiving anticoagulant therapy); 7. Patients with positive screening for infectious diseases: positive for HBsAg, HCV-Ab, HIV-Ab, or TP-Ab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate of HU in transplanted bone; | — |
Secondary
| Measure | Time frame |
|---|---|
| Two point discrimination of lower lip;University of Washington Quality of Life Scale;Bone flap blood supply; | — |
Countries
China
Contacts
Public ContactLei Wang
Shanghai Ninth People's Hospital
Outcome results
None listed