Hemi-tibial plateau osteotomy versus high tibial osteotomy with arthroscopic medial meniscus posterior root repair
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
This study tests whether a newer hemi-tibial plateau osteotomy plus arthroscopic meniscus repair helps people with varus-aligned knees and medial meniscus posterior root tears improve more than the standard high tibial osteotomy plus repair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Sponsor | Eighth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07356674 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized surgical comparison will enroll about 20 patients with varus knee alignment and MRI-confirmed medial meniscus posterior root tears. Participants will be randomized to either hemi-tibial plateau osteotomy combined with arthroscopic repair or standard high tibial osteotomy combined with arthroscopic repair. The primary clinical outcome is change in Lysholm knee function score at 12 months, with secondary outcomes including pain, imaging findings, meniscal healing, complications, length of hospital stay, and preliminary cost data. Safety and hospital-related costs will be tracked alongside clinical and imaging outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35–75 with varus knee deformity predominantly from the tibia (varus angle <10° and medial proximal tibial angle <87°), MRI-confirmed medial meniscus posterior root tear, medial joint space narrowing with Kellgren-Lawrence grade < IV, and persistent symptoms after at least one month of conservative treatment.
Not a fit: Patients with advanced knee osteoarthritis (Kellgren-Lawrence grade IV), large varus deformities (≥10°), tears that are not posterior root lesions, or those unable/unwilling to undergo surgery or follow-up are unlikely to benefit from the procedures tested here.
Why it matters
Potential benefit: If successful, the newer procedure could provide better knee function and pain relief while promoting meniscal healing and possibly shortening hospital stay or lowering short-term costs.
How similar studies have performed: High tibial osteotomy combined with meniscal repair has supporting prior data, while hemi-tibial plateau osteotomy is a newer variation with limited published evidence.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Shenzhen, Guangdong
- The Eighth Affiliated Hospital, Sun Yat-Sen University — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hanting Yi
- Email: yiht6@mail2.sysu.edu.cn
- Phone: 852-52091055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.