Bone defects of the limbs
Conditions
Interventions
Control group:Use of ß-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.
Sponsors
Fourth Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age > = 18 years old and =1cm^3 and <=8cm^3, and there was only one bone defect requiring intervention; 4. The study participant or his/her guardian can understand the purpose of the study, demonstrate adequate compliance with the study protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Open fracture with wound contamination; 2. Repair of infectious bone defects; 3. Structural bone grafting is required for the defect site; 4. Proposed surgical limb with compartment syndrome; 5. Combined with systemic infection or uncontrolled local infection at the surgical site, malignant tumor (including metastases) at the defect site, osteonecrosis at the defect site, severe nerve damage/soft tissue injury/vascular injury at the defect site, confirmed severe malnutrition or other important organ failure; 6. Abnormal metabolism of calcium and phosphorus (calcium and phosphorus exceed 1.5 times of the upper limit of normal); 7. Patients with a history of diabetes mellitus and fasting blood glucose = 6.1mmol/L; 8. Coagulation dysfunction (PT or APTT more than 2 times the upper limit of normal); 9. Use of chemotherapy drugs and radiotherapy within 3 months before enrollment; 10. Cumulative use of corticosteroids or growth factors for 14 days within 1 month prior =to enrollment; 11. Long-term use of sedative-hypnotic drugs (more than 3 months of continuous use) and long-term use of non-steroidal anti-inflammatory drugs (more than 3 months of continuous use); 12. Known allergies to bovine-derived materials and collagen products; 13. Pregnant or lactating females; 14. Participated in the interventional clinical trial of other drugs or medical devices within 1 month before enrollment; 15. Other situations in which the investigator believes that the investigator should not participate in this clinical trial for the benefit of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone graft fusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone defect healing rate;New bone formation rate;SF-36 scale;Medical Device Operational Performance Evaluation; | — |
Countries
China
Contacts
Public ContactWei Zhang
Chinese PLA General Hosptial
Outcome results
None listed