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This study is a prospective, randomized, controlled, double-arm, non-inferiority study that will be carried out in China. It aims to compare two implant systems (the research group uses surface-modified composite coated orthopedic implants, and controls group using conventional orthopedic implants) safety and effectiveness. A total of 240 patients were recruited. The recruited patients are randomly divided into groups at a ratio of 1:1 to ensure that the distribution of patients in the treatment group and the control group is consistent. Patients will receive clinical follow-up in the 1, 3, 6, 9 and 12 months postoperatively. The main indicator for evaluation is the postoperative infection rate, and the secondary indicators include the SF-12 scoring scale, EQ-5D patient questionnaire score, fracture healing, malunion, nonunion incidence in the 12th month after surgery, and skin and soft tissue complications Symptom incidence rate. The follow-up data will be used to determine the main safety and effectiveness of the new surface modified composite coated orthopedic implant system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Research Group | Experimental | Research group uses surface-modified composite coated orthopedic implants |
|
| Controls Group | Active Comparator | Controls group uses conventional orthopedic implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surface-modified composite coated orthopedic implants | Device | The surface-modified composite coated orthopedic implants have the capacity of high binding strength, high tissue-inducing activity and intelligent bacteria-resistance. The implant devices are expected to be used in the prevention and treatment of plant-related infections in orthopedic surgeries. |
| Measure | Description | Time Frame |
|---|---|---|
| post-operation infection rate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| SF-12 score | 12 months | |
| EQ-5D score | 12 months | |
| fracture union, malunion, nonunion rate |
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Inclusion Criteria:
Limb fracture group criteria
Joint replacement group criteria
Spine patients group criteria
Exclusion Criteria:
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|
| conventional orthopedic implants | Device | conventional orthopedic implants |
|
| 12 months |
| ID | Term |
|---|---|
| D005597 | Fractures, Open |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D009140 | Musculoskeletal Diseases |
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