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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT04927104
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects aged 55 years of age or older and less than 74 years of age, younger subjects should have urgent need for surgery.
* Subjects skeletal maturity.
* Subjects appropriate for total knee replacement, such as noninflammatory degenerative joint diseases (such as osteoarthritis, traumatic arthritis, or ischemic necrosis); Inflammatory degenerative joint diseases (including rheumatoid arthritis); Correction of functional deformity.
* The diseased side knee appropriate for primary total knee arthroplasty .
* Subjects or guardian is willing and able to sign the informed consent form .
Exclusion Criteria:
* Subjects with knee instability or abnormal gait caused by neuromuscular insufficiency.
* Subjects with bilateral knee joint disease who are expected to require replacement of both knees during the course of the study (i.e., within the next 12 months) .
* Alcoholics, drug addicts and drug abusers.
* Subjects with severe diabetes (fasting blood glucose \> 10mmol/L)
* Body Mass Index, BMI\>35.
* Female subjects who are pregnant or lactating.
* Subjects have disease limited their participation in the investigation or have an existing condition that would compromise their participation and follow-up in this clinical investigation.
* In the month before inclusion, subjects who participated in clinical studies of other drugs, biological agents or medical devices and failed to meet the main research endpoints.
* Other conditions, in the opinion of the Investigator, are inappropriate for participation in this clinical investigation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
74 Years
Study:
NCT04927104
Study Brief:
Protocol Section:
NCT04927104