None listed
Conditions
Interventions
Medical Device : This trial will be conducted according to the concept of “interventional trial” and random allocation codes will be generated so that the ratio of subjects in the trial group or contr
Sponsors
CnS medical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those aged 19 or older and under 80 years old 2) Those who meet at least one of the following four criteria: - Those with a distal tibia fracture - Those with a fibula fracture - Those with a distal radius fracture - Those who require radial surgery due to malunion after a distal radius fracture or nonunion after a distal radius fracture 3) Those who have received a sufficient explanation of the purpose and content of the clinical trial and voluntarily signed a written consent form
Exclusion criteria
Exclusion criteria: 1) Those who have previously had surgery on the same surgical site 2) Those who have a comminuted fracture and the fracture fragments are composed of very small pieces, making it difficult to expect safety through fixation 3) Those who are judged to have delayed bone fusion due to alcohol abuse, other metabolic diseases, or general conditions 4) Those with active or latent infections 5) Those with high hypersensitivity to the implant (if hypersensitivity is suspected, a test is performed prior to implantation.) 6) Those with severe osteoporosis that makes surgical operation difficult 7) Those with sepsis 8) Those with insufficient quality or quantity of bone or soft tissue 9) Those who are pregnant or breastfeeding 10) Those who have difficulty participating in the clinical trial due to the investigator's judgment or other reasonsv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of fracture union rates between the experimental and control groups at 12 weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Between-group comparison of delayed fracture union rates at 24 weeks after surgery between the test group and the control group;Between-group comparison of inflammation and infection levels through blood tests at each observation time between the test group and the control group;Between-group comparison of antibiotic use duration (hours) at each observation time between the test group and the control group;Between-group comparison of ankle or wrist joint range of motion (ROM) at each observation time between the test group and the control group;Between-group comparison of screw and metal plate fracture at each observation time between the test group and the control group;Between-group comparison of VAS scores at each observation time between the test group and the control group;Adverse event;vital signs;Physical examination;Laboratory tests | — |
Countries
Korea, Republic of
Contacts
Public ContactLee Ki Hwa
Korea University Anam Hospital
Outcome results
None listed