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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07395856
Eligibility Criteria:
Inclusion Criteria:
* diagnostic criteria for primary knee osteoarthritis (KOA) as defined by the "Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2019 Edition)."
* Aged between 18 and 75 years.
* No history of trauma or surgery involving the lower limbs. Scheduled to undergo total knee arthroplasty (TKA) performed by the same surgical team at the participating hospital.
* Willing to refrain from participating in any other clinical research studies for the duration of this trial.
* Agrees to adhere to the complete study treatment regimen.
* Able and willing to provide written informed consent.
Exclusion Criteria:
* Has a preoperative knee joint infection, rheumatoid arthritis, or other concurrent inflammatory or non-inflammatory joint disease.
* Has a history of any prior knee surgery (including revision procedures).
* Has diabetes mellitus with poorly controlled glucose levels (fasting blood glucose \>7.2 mmol/L or 2-hour postprandial blood glucose \>11.1 mmol/L).
Has severe, unstable, or uncontrolled disease of the circulatory, respiratory, or hematopoietic systems.
* Has obesity defined as a body mass index (BMI) ≥30 kg/m².
* Has a diagnosis of severe osteoporosis.
* Is pregnant or currently breastfeeding.
* Has an active psychiatric disorder or any other condition that, in the investigator's judgment, would impair the ability to provide informed consent or comply with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07395856
Study Brief:
Protocol Section:
NCT07395856