Internal fixation, osteotomy and arthrodesis of various non bearing parts
Conditions
Interventions
Experimental group:Use the absorbable composite screw produced by Chengdu Dikang biomedical materials Co., Ltd
control group:Use the absorbable bone screws produced by Changchun Shengboma Biological Materials Co.,Ltd.
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) The subject or guardian is willing and able to sign the informed consent; 2) Aged 18-65 years; 3) Fresh fracture patients; 4) Patients who need internal fixation, osteotomy and arthrodesis of non load bearing fracture; 5) Good compliance, willing and able to follow up as required.
Exclusion criteria
Exclusion criteria: 1) Local infection of the whole body or operation site; 2) Patients with osteomyelitis; 3) Pathological fracture of operation site; 4) Fracture with osteofascial compartment syndrome; 5) Metabolic osteopathy (except osteoporosis in the elderly); 6) Patients with malignant tumor; 7) Severe multiple injuries (with severe brain injury or multiple organ injury, etc.); 8) Patients who are systematically using corticosteroids; 9) Patients using growth factors; 10) Long term use of sedative and hypnotic drugs (continuous use for more than 3 months); 11) Long term use of non steroidal anti-inflammatory drugs (continuous use for more than 3 months); 12) Those who are allergic to the materials used in the product; 13) Lactating or pregnant women; 14) Mental illness, drug abuse, alcoholism; 15) Severe heart, liver, kidney, lung, blood system and other diseases can not tolerate surgery; 16) Subjects participated in other clinical studies 3 months before selection; 17) Other situations in which patients are not considered suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fracture healing rate at 6 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficiency of comprehensive evaluation;Fracture healing rate at 6 weeks and 12 weeks after operation;Performance evaluation of the product during operation; | — |
Countries
China
Contacts
Public ContactChangqing Zhang
Shanghai Jiaotong University Affiliated Sixth People's Hospital, Shanghai
Outcome results
None listed