๐ฌIn plain words
What the trial is, and whether it could suit you
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 enro
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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/mยฒ.
* 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.