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

Official title

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

Overview

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.

Interventions

• Procedure Hemi-tibial plateau osteotomy combined with arthroscopic repair
  The intervention is hemi-tibial plateau osteotomy combined with arthroscopic repair of the medial meniscus posterior root (HTPO combined with arthroscopic repair). After anesthesia and supine positioning, the medial compartment is opened by releasing the distal attachment of the superficial medial collateral ligament. Under fluoroscopic guidance, an L-shaped osteotomy is performed with the horizontal cut approximately 3.0 cm below the tibial plateau, while preserving the articular surface contin
• Procedure High tibial osteotomy combined with arthroscopic repair
  The control intervention is high tibial osteotomy combined with arthroscopic repair of the medial meniscus posterior root (HTO combined with arthroscopic repair). After anesthesia and supine positioning, the high tibial osteotomy is performed under fluoroscopic guidance according to the preoperative plan. A controlled valgus force is gradually applied to open the osteotomy gap, and the lower-limb alignment is corrected to the preplanned target and confirmed by fluoroscopy. Arthroscopic evaluatio

Primary outcome measures

• Change From Baseline in Lysholm Knee Score (12 months) [Time frame: Baseline (preoperative) and 12 months after surgery]

Secondary outcome measures (4)

• Change From Baseline in Lysholm Knee Score (3 and 6 Months) [Time frame: Baseline (preoperative), 3 months, and 6 months after surgery]
• Change From Baseline in WOMAC Total Score (3, 6, and 12 Months) [Time frame: Baseline (preoperative), 3 months, 6 months, and 12 months after surgery]
• Change From Baseline in Pain Score (VAS) (3, 6, and 12 Months) [Time frame: Baseline (preoperative), 3 months, 6 months, and 12 months after surgery]
• Change in Mechanical Axis Location on Tibial Plateau (%MA) on Full-Length Lower Limb Radiographs [Time frame: Baseline (preoperative), 3 months, 6 months, and 12 months after surgery]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• The Eighth Affiliated Hospital, Sun Yat-Sen University — Shenzhen

Identifiers

NCT: NCT07356674 · ZDBY-IIT-202503-032

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗