Hemi-tibial Plateau Osteotomy Combined With Arthroscopic Repair for Medial Meniscus Posterior Root Tears in Varus Knees: A Pilot Randomized Controlled Trial

This is a single-center clinical trial started by the study team. The goal is to compare two surgeries for people who have a varus knee alignment and a tear at the back attachment of the medial meniscus. Researchers want to learn how the newer bone-cut procedure with arthroscopic meniscus repair compares to the standard bone-cut procedure with arthroscopic meniscus repair. Researchers will also track safety and hospital-related costs.

Main questions the study aims to answer:

• At 12 months after surgery, how does the improvement in knee function compare between the newer-surgery group and the standard-surgery group? The study will evaluate preliminary trends in clinical efficacy using the Lysholm knee function score.
• Do the two groups differ in pain relief, imaging findings, meniscus healing, complications, and hospital stay and preliminary cost-effectiveness? The study plans to enroll about 20 participants at Sun Yat-sen University Eighth Affiliated Hospital (Shenzhen Futian). Participants will be assigned by chance, like drawing lots, in a one-to-one ratio. This is an pilot study with a PROBE (Prospective Randomized Open-label Blinded-Endpoint) design. While participants and surgeons will know which surgery is performed, the research assistant responsible for collecting patient-reported outcomes will be blinded to group allocation to minimize observer bias.

Study groups:

• Experimental group: hemi-tibial plateau osteotomy plus arthroscopic meniscus repair.
• Control group: high tibial osteotomy plus arthroscopic meniscus repair.

Who may join:

• Age 35 to 65 years, with no restriction on sex;
• Diagnosed with a medial meniscus posterior root tear;
• Presence of varus knee deformity;
• Imaging findings support the diagnosis (e.g., knee MRI);
• Failure of conservative treatment: no meaningful improvement after more than 1 month of non-surgical management (e.g., rest, medication, or physical therapy);
• Varus alignment angle less than 10 degrees;
• The deformity is predominantly tibial in origin;
• Knee radiographs do not show the most severe osteoarthritis (Kellgren-Lawrence grade other than IV).

Who cannot join:

• A knee that is chronically "locked," meaning it cannot bend or straighten normally.
• The most severe level of knee arthritis on knee X-ray.
• Severe arthritis in the hip or ankle that could affect knee function testing.
• Inflammatory or infectious conditions that can affect the knee, or abnormal inflammation blood tests that make participation unsafe.
• Knee instability or poorly functioning prior ligament reconstruction, based on the study doctor's judgment.
• Any prior surgery on the target knee, or on other joints of the same-side lower limb.
• Serious heart, liver, or kidney disease, cancer, bleeding disorders, immune deficiency, or severe mental health conditions that make participation unsafe.
• Body mass index of 30 or higher.
• Pregnancy or breastfeeding, or not willing to use birth control during the study.
• Participation in another clinical study within the past 3 months (except registry studies).
• Any other reason the study doctor believes makes participation unsafe or not appropriate.

What participants will do:

• Complete screening and baseline assessments within about 30 days before surgery and sign informed consent.
• Receive the assigned surgery during the hospital stay.
• Return for follow-up visits at 3 months, 6 months, and 12 months after surgery.
• Complete knee function and symptom questionnaires and rate pain at each follow-up visit.
• Have standing knee X-rays and full-length leg X-rays at 3, 6, and 12 months.
• Have an MRI of the operated knee at 3, 6, and 12 months to assess meniscus healing and meniscus extrusion.

Outcomes:

• Primary outcome: change from baseline to 12 months in the Lysholm knee function score.
• Secondary outcomes: changes in the Lysholm score at 3 and 6 months; changes in the WOMAC knee arthritis symptom score at 3, 6, and 12 months; changes in pain rating on a standard pain scale at 3, 6, and 12 months; imaging measures and bone healing on X-rays; meniscus healing and extrusion on MRI; surgery time and blood loss; complications during and after surgery; length of hospital stay and hospital costs; and quality of life utility value from a standard health questionnaire.