30/5000 Filling of non-load-bearing bone defect in orthopaedic surgery
Conditions
Interventions
Control Group:ß-Tricalcium phosphate bioceramics
Trial Group:Magnesium-containing biodegradable polymer bone repair materials
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years and = 0.5 cm and <= 6 cm, the defect is only 1; 4. The bone defect is expected to be fixed with a nondegradable internal fixation system; 5. The subject or his or her legal representative can understand the purpose of the study, demonstrate sufficient adherence to the protocol, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Unstable glycemic control that precludes surgical conditions 2. Severe Coagulopathy (PT or Aptt >= 2 times the upper normal value); 3. A history of arterial thrombosis (stroke, Angina, acute myocardial infarction, etc.) or NYHA grade >= III WITHIN 3 months prior to admission; 4. Taking or injecting sedative hypnotics or non-steroidal anti-inflammatory drugs (except aspirin) every week for 3 months prior to admission; 5. Receiving chemotherapy or radiotherapy within 3 months prior to admission; 6. Oral or injection of corticosteroid hormones or growth factors >= 14 days within 1 month prior to admission; 7. Complicated with systemic infection or uncontrolled local infection, severe soft tissue injury to the surgical site, severe vascular or severe nerve injury, malignant tumor, severe malnutrition diagnosed or other major organ failure; 8. Limb with Osteofascial Compartment Syndrome; 9. Requiring structural bone grafting; 10. Pregnant or lactating women; 11. Participating in clinical trials of other drugs or medical devices within one month prior to admission; 12. Other circumstances in which the researcher considers it in the interest of the subject that he or she should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of bone graft fusion at 24 weeks postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of bone graft fusion 12 weeks after operation;Rate of bone graft fusion 36 weeks after operation;Improvement of SF-36 scale at 36 weeks after operation;Evaluation of Instrument Operation Satisfaction; | — |
Countries
China
Contacts
Public ContactXieYuan Jiang
Beijing Jishuitan Hospital
Outcome results
None listed