Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT04481269
Eligibility Criteria:
Inclusion Criteria:
* Limb fracture group criteria
1. Age 18-75 years old, no gender limit
2. The preoperative diagnosis is clearly Anderson-Gustilo type III open fracture patient
3. Postoperative diagnosis stage is IIIA or IIIB patients with open fracture
4. The subject understands the meaning of this project, volunteers to be the subject, and signs to be informed consent
* Joint replacement group criteria
1. Age 40-75 years old, no gender limit
2. The patient is clearly diagnosed as degenerative osteoarthritis before the operation, and the postoperative diagnosis is the same as before the operation
3. Patients can tolerate implantation operation
4. The subject understands the meaning of this project, volunteers to be the subject, and signs to be informed consent
* Spine patients group criteria
1. Age 40-75 years old, no gender limit
2. Before surgery, it is clearly diagnosed as degenerative spine disease and spine requiring intervertebral fusion
3. Patients can tolerate implantation operation
4. The subject understands the meaning of this project, volunteers to be the subject, and signs to be informed consent
Exclusion Criteria:
* 1\. The subject is pregnant or breastfeeding, or a woman of childbearing age does not agree to take effective contraceptive measures during the period 2. Closed fractures or pathological fractures (such as primary or metastatic tumors) 3. Patients with symptoms of compartment syndrome 4. According to Gustilo-Anderson classification of open fractures into type I and type II patients 5. Multiple injuries, determined by the researcher to be unsuitable for research 6. The patient is allergic to metal plants 7. Combined with certain medical diseases, it is determined by the investigator to be unsuitable for the study, for example metabolic bone disease, sequelae of polio, poor bone quality, poor bone healing 8. The patient has participated in other clinical trials in the past 3 months 9. The patient has contraindications to anesthesia and surgery 10. Patients with congenital malformations, local or systemic infections, skin diseases 11. The patient is currently receiving chemotherapy or radiotherapy, systemic corticosteroid, long-term use of sedative and hypnotics (using more than 3 consecutive months) or non-steroidal anti-inflammatory drugs (continuous use for more than 3 months) 12. The patient's compliance is poor, and the research staff determines that it cannot be completed according to the research plan. No consent for voluntary participation in clinical research was provided.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04481269
Study Brief:
Protocol Section:
NCT04481269