Patients with fractures or fusions of the hand or foot requiring surgery.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18~70 years old, both male and female; 2. Screw fixing is used for the first time; 3. Subjects with fractures or fusions of the hand or foot requiring surgery; 4. Voluntary participation and signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. pathological fractures due to bone disease (benign or malignant tumors, tuberculosis, osteomyelitis, endocrine metabolic and other factors). 2. patients with anatomical anomalies and excessive bending of the diaphysis. 3. the implant is expected to be subjected to high mechanical loads. 4. severe comminuted fractures, osteoporosis that prevents effective fixation of the implant. 5. fractures with localized soft tissue damage and defects without adequate tissue coverage at the implant site. 6. at sites of bone marrow inflammation, septic infection, or other soft tissue infection. 7. patients with suspected or confirmed allergy to the implanted material. 8. Patients with contraindications to anesthesia and surgery; 9. Pregnant and breastfeeding women; 10. patients with co-morbid rheumatologic diseases that may affect the evaluation of the test results as assessed by the investigator; 11. the presence of sensory deficits which, as assessed by the investigator, affect the evaluation of the results of the test. 12. the presence of a psychiatric disorder that, in the opinion of the Investigator, affects the evaluation of the results of the trial. 13. any condition that, in the opinion of the Investigator, may increase the risk to the subject or interfere with the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture healing rates in subjects with hand and foot fractures or fusions at 6 months after surgery.; | — |
Countries
China
Contacts
The First Hospital of Jilin University