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Hemi-tibial plateau osteotomy combined with arthroscopic repair for medial meniscus posterior root tears in varus knees: A single-center, randomized, controlled, open-label, non-inferiority study

Hemi-tibial plateau osteotomy combined with arthroscopic repair for medial meniscus posterior root tears in varus knees: A single-center, randomized, controlled, open-label, non-inferiority study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115122
Enrollment
Unknown
Registered
2025-12-23
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

Experimental Group:Hemi-tibial plateau osteotomy

Sponsors

The Eighth Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years

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

MeasureTime frame
Lysholm Knee Score;

Secondary

MeasureTime 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

Public ContactMengjun Ma

The Eighth Affiliated Hospital Sun Yat-sen University

mamj8@mail.sysu.edu.cn+86 13682311357

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026