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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT06856356
Eligibility Criteria:
Inclusion Criteria:
1. Subjects voluntarily participate in the trial and sign the informed consent form;
2. Aged 18 to 80 years old (inclusive), regardless of gender;
3. Patients who need total knee replacement surgery;
4. Those who can communicate well with the researchers and comply with the trial requirements.
Exclusion Criteria:
1. Patients who are allergic to the drugs used in this trial or the implant materials;
2. Patients with immature bone development;
3. Patients with active infection;
4. Patients with neuropathy of the knee joint;
5. Patients with poor bone quality that is not conducive to prosthesis fixation;
6. Patients with general conditions or concomitant diseases that make it difficult for people to tolerate surgery;
7. Patients with insufficient quadriceps muscle strength;
8. Patients with insufficient skin coverage near the surgical site and intolerance to surgery;
9. Patients with severe femoral or tibial deformities and other severe deformities outside the joint;
10. Patients with metal implants in the joint surgical area that affect the execution of the surgical plan;
11. Pregnant or lactating women;
12. Patients with severe epilepsy or mental illness;
13. Patients with alcohol dependence or drug addiction;
14. Patients with severe coagulation disorders;
15. Patients who have participated in or are participating in other clinical trials within one month of enrollment;
16. Patients who are considered by the researchers to be unsuitable for participating in this clinical trial for other reasons. Those who meet any of the above exclusion criteria need to be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06856356
Study Brief:
Protocol Section:
NCT06856356