Bone defects of the limbs
Conditions
Interventions
Intervention group:The plastic artificial bone repair material produced by Wuxi Bedi Bioengineering Co., Ltd. is used
Control group:The ß-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd. are used
Sponsors
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 18~70 years old, gender is not limited; 2) Repair of bone defects such as lacunar bone defects after resection of complex limb bone defects and bone cysts caused by trauma; 3) Subjects voluntarily participate in this clinical trial and sign the informed consent form; 4) Subjects have good compliance, are willing and able to undergo follow-up observation as required
Exclusion criteria
Exclusion criteria: 1) Large bone defect (defect length= 4 cm); 2) Serious heart, liver, kidney, hematopoietic, endocrine system and other diseases; Patients with contraindications to anesthesia and surgery; 3) Patients with systemic infection or severe local infection; 4) Patients with open fractures and wound contamination; 5) Patients with malignant tumors; 6) Patients with bone defects accompanied by severe soft tissue, nerve and blood vessel damage; 7) Patients with compartment syndrome; 8) Structural bone grafters; 9) Severe multiple injuries; 10) Those who use chemotherapy drugs or receive radiotherapy; 11) Patients with heart, brain, liver, kidney, blood system, endocrine system, immune system (such as AST, ALT, creatinine= 2.0 ULN, fasting blood glucose =8.0mmol/L) and other serious primary diseases that cannot tolerate surgery; 12) Long-term use of corticosteroids (continuous use for more than one month); 13) Mental illness, substance abuse, alcoholism; 14) Those who use growth factors and drugs that affect bone healing; 15) Those who are known to be allergic to bovine-derived materials and collagen products; 16) Those who have a positive pregnancy test, pregnant or lactating women, and those who have recently planned to have children; Those who are unable to use feasible contraceptive measures during the trial: 17) Those who have participated in clinical studies of other drugs, biological agents or medical devices before enrollment and have not reached the primary endpoint timeframe; 18) Other circumstances that the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone graft fusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone defect healing;SF-36 scale;Safety evaluation; | — |
Countries
China
Contacts
Public ContactZheng Xianyou
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed