Patients with broken limbs requiring internal fixation
Conditions
Interventions
Intervention group:Implanted spicules
Sponsors
Affiliated Zhongshan Hospital of Dalian University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily signed the informed consent; 2. The age is 18~75 years old (inclusive), and the gender is not limited; 3. Patients with broken limbs requiring internal fixation with gram needles; 4. Good compliance, willing and able to perform treatment and follow-up observation as required.
Exclusion criteria
Exclusion criteria: 1. Patients with systemic or local infection at the surgical site; 2. Pathological fracture of the surgical site; 3. Patients with myelitis; 4. Serious soft tissue, nerve, and duct injury at the fracture site; 5. folded with fascial compartment syndrome; 6. Serious defect of the surgical site; 7. Severe multiple injuries (with severe craniocerebral injury or multiple organ injury, etc.); 8. Investigators judged the presence of osteoporosis through the medical history and X-rays of the fracture site; 9. History of chemotherapy drug treatment within 1 year; 10. History of radiotherapy within 1 year; 11. Systemic use of corticosteroids; 12. Use growth factor; 13. Long-term use of sedative and hypnotic drugs (more than 3 months of continuous use); 14. Long-term use of non-steroidal anti-inflammatory drugs (continuous use of more than 3 months); 15. Drug abusers, alcoholics; 16. Those who smoke >=10 per day; 17. Patients who are known to be allergic to antibacterial titanium alloy needle material (Ti-Cu alloy); 18. Women who are breastfeeding or pregnant; 19. Participants who had participated in clinical trials of other drugs or medical devices before enrollment but did not meet the primary study endpoint time limit; 20. The subjects' co-existing diseases limit their participation in the study, their compliance with follow-up, or the scientific integrity of the study; 21. Other conditions in which the patient was considered inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Product effectiveness at 24 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fracture union rate at 12 weeks postoperatively;Incidence of infection;Product operation performance; | — |
Countries
China
Contacts
Public ContactDewei Zhao
Affiliated Zhongshan Hospital of Dalian University
Outcome results
None listed