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Hemi-tibial Plateau Osteotomy Combined With Arthroscopic Repair for Medial Meniscus Posterior Root Tears in Varus Knees

RecruitingNAAges 35 Years - 75 YearsAllEighth Affiliated Hospital, Sun Yat-sen University
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In 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.

๐Ÿ“‹ 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.
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What it tests

  • Hemi-tibial plateau osteotomy combined with arthroscopic repair
  • High tibial osteotomy combined with arthroscopic repair
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Where

1 site
The Eighth Affiliated Hospital, Sun Yat-Sen University
Shenzhen, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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