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 tr…
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.
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Eligibility Criteria
Inclusion Criteria:
* Age 35 to 75 years, with no restriction on sex.
* Clinical features suggestive of a medial meniscus posterior root tear, including at least one of the following symptoms: knee locking, clicking, or medial knee pain; and at least one of the following signs: medial joint line te…
Inclusion Criteria:
* Age 35 to 75 years, with no restriction on sex.
* Clinical features suggestive of a medial meniscus posterior root tear, including at least one of the following symptoms: knee locking, clicking, or medial knee pain; and at least one of the following signs: medial joint line tenderness or a positive McMurray test.
* Varus knee deformity with a varus angle of less than 10 degrees, with the deformity predominantly originating from the tibia (i.e., medial proximal tibial angle less than 87 degrees).
* Knee MRI demonstrates a medial meniscus posterior root tear.
* Knee radiographs show narrowing of the medial joint space, and Kellgren-Lawrence grade less than IV.
* Failure of conservative treatment (e.g., rest, medication, or physical therapy) for more than 1 month.
* Willing to accept randomization and able to understand and sign the informed consent form.
* For participants with bilateral deformity, the more severely deformed side will be selected as the operative (study) side.
Exclusion Criteria:
* Chronic knee locking (e.g., the participant cannot bend or fully straighten the knee).
* Kellgren-Lawrence grade IV knee osteoarthritis.
* Osteoarthritis or other conditions in other joints (e.g., hip or ankle) that may affect assessment of knee function.
* Known inflammatory diseases or other conditions that may affect knee function, including but not limited to: autoimmune diseases (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus); crystal-induced arthritis (gout, pseudogout); secondary knee osteoarthritis due to trauma or other diseases; active knee joint infection or a history of knee joint infection; reactive arthritis; systemic cartilage disorders; systemic connective tissue diseases; metabolic bone disease; fracture (acute or subacute fracture within 6 months prior to the screening visit); osteonecrosis; or abnormal inflammatory markers (C-reactive protein or high-sensitivity C-reactive protein at least 2 times the upper limit of normal, or erythrocyte sedimentation rate at least 3 times the upper limit of normal), if judged by the investigator to be unsuitable for participation.
* Target-knee instability (including but not limited to post-traumatic or congenital laxity) or inadequate ligament reconstruction, as judged by the investigator.
* Any prior surgery on the target knee or on other joints of the ipsilateral lower limb.
* Serious cardiac disease; hepatic impairment (aspartate aminotransferase or alanine aminotransferase at least 3 times the upper limit of normal, or total serum bilirubin at least 1.5 times the upper limit of normal); renal impairment (serum creatinine at least 1.5 times the upper limit of normal); other musculoskeletal disorders; malignancy; coagulation disorders; immunodeficiency; or psychiatric disorders, if judged by the investigator to be unsuitable for participation.
* Body mass index at least 30 kg/m².
* Pregnant or breastfeeding women, or participants (including men and women) unwilling to use contraception during the study period.
* Participation in another clinical study within 3 months prior to enrollment (excluding registry studies).
* Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation.
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