Fractures of the limbs
Conditions
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) age >=18 years old and <=65 years old, both sexes; 2) for limb fractures caused by various reasons, fracture reduction and fixation should be performed; 3) one or two fractures located in different limb bones; 4) subjects or their legal representatives can understand the purpose of the study, demonstrate adequate compliance with the study protocol, and sign informed consent.
Exclusion criteria
Exclusion criteria: 1) combined with systemic infection or uncontrolled local infection, severe soft tissue injury at the planned operation site, severe vascular or severe nerve injury, malignant tumor, or confirmed diagnosis 2) severe malnutrition or other vital organ failure; 3) weekly oral or injectable sedatives/hypnotics or non-steroidal anti-inflammatory drugs (except aspirin) during the 3 months before screening; 4) receiving chemotherapy or radiotherapy within 3 months before or during the screening period; 5) At least 14 days of oral corticosteroids or growth factor injections within 1 month before or during the screening period; 6) the limb to be operated on has osteofascial compartment syndrome; 7) pregnant or lactating women; 8) other situations where the investigator considers that the subject should not participate in the clinical trial for the benefit of the subject, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture healing rate 24 weeks after surgery;Instrument operation satisfaction assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fracture healing rate 12 weeks after surgery;Fracture healing time, etc;SF-36 scale score;Incidence of adverse events;Incidence of device defects;Use of fixation devices;Fracture reduction evaluation, etc; | — |
Countries
China
Contacts
Public ContactYe Zhaoming
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed