comminuted distal radius fractures
Conditions
Sponsors
The Affiliated Sir Run Run Shaw 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 and <= 65 years, gender unrestricted; 2) Comminuted distal radius fractures caused by various, requiring fracture reduction and fixation surgery; 3) The participant or their legal representative can understand the purpose of the study, demonstrates sufficient compliance with the study protocol, signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Combining systemic infection or uncontrolled local infection, severe soft tissue damage at the proposed surgical site, severe vascular or nerve damage, malignant tumor, diagnosed severe malnutrition or other important organ failure; 2) Previous history of distal radius fractures on the same wrist; 3) Open distal radius fracture; 4) Combining hand injuries with navicular bone fractures or other factors that affect functional recovery; 5) Take oral or injection sedatives, hypnotics, or nonsteroidal anti-inflammatory drugs (excluding aspirin) every week within the first 3 months of screening; 6) Have received chemotherapy drugs or radiation therapy within the previous 3 months or during the screening period; 7) Accumulated oral or injectable corticosteroids or various growth factors for at least 14 days within the month prior to screening or during the screening period; 8) The limb to be operated on is complicated with osteofascial compartment syndrome; 9) Merge bone defects planned for non autogenous bone implantation; 10) Pregnant or lactating women; 11) Combining severe heart, lung, liver, kidney, hematological or metabolic diseases that cannot tolerate surgery; 12) Screening for participation in other clinical trials that may affect this trial within the previous 3 months; 13) For the benefit of the subjects, the researchers believe that they should not participate in other situations of this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture healing rate 24 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fracture healing rate 12 weeks after surgery;Joint function;Radiographic reduction;SF-36 scale score;Instrument operation satisfaction assessment;Incidence of adverse events;Incidence of device defects; | — |
Countries
China
Contacts
Public ContactQiang Wang
The Affiliated Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Outcome results
None listed