Knee osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 35–65 years, regardless of gender; 2.Clinical evidence of medial meniscus tear, meeting the following criteria: At least one symptom: Locking, clicking, or medial knee pain. At least one sign: Medial joint line tenderness or positive McMurray’s sign; 3.Presence of varus deformity with a varus angle =1 month; 7.Willingness to undergo randomization and ability to comprehend and sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1.Chronic knee joint locking (e.g., inability to flex or extend the knee); 2.Kellgren-Lawrence Grade IV osteoarthritis (severe joint space narrowing or bone deformity); 3.Osteoarthritis in other joints (e.g., hip, ankle) that may interfere with knee function assessment; 4.Comorbid inflammatory or other conditions affecting knee function, including but not limited to: Autoimmune diseases (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus); Crystal-induced arthritis (e.g., gout, pseudogout); Secondary knee osteoarthritis due to trauma or disease; Active or prior knee joint infection; Reactive arthritis, generalized cartilage disorders, systemic connective tissue diseases, metabolic bone diseases; Acute or subacute fractures within 6 months prior to screening; Avascular necrosis; Elevated inflammatory markers (CRP/hs-CRP >=2×ULN; ESR >=3×ULN). Subjects deemed ineligible by the investigator due to the above conditions; 5.Target knee instability (e.g., post-traumatic or congenital laxity) or inadequate ligament reconstruction, as determined by the investigator; 6.Prior surgery on the target knee or ipsilateral lower limb joints; 7.Severe comorbidities judged ineligible by the investigator, including: Cardiac disease; Hepatic dysfunction (AST/ALT >=3×ULN; total bilirubin >=1.5×ULN); Renal insufficiency (serum creatinine >=1.5×ULN); Musculoskeletal disorders, malignancies, coagulation disorders, immunodeficiency, or psychiatric conditions; 8.Body mass index (BMI) >=30 kg/m^2; 9.Lactating or pregnant individuals or subjects refusing contraception during the study (applies to all genders); 10.Participation in another clinical trial within 3 months prior to enrollment (excluding registrational studies); 11.Other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lysholm Knee Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intra-articular parameters of the knee joint;Full-length lower limb radiographic angle measurement;WOMAC Osteoarthritis Index;Lower limb alignment;VAS Pain Score;EuroQol 5-Dimension 5-Level questionnaire; | — |
Countries
China
Contacts
The Eighth Affiliated Hospital Sun Yat-sen University