Actively Recruiting

Phase Not Applicable
Age: 35Years - 75Years
All Genders
NCT07356674

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

Led by Eighth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-05-04

20

Participants Needed

1

Research Sites

148 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 35Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 35 to 75 years, no restriction on sex
  • Clinical signs of medial meniscus posterior root tear such as knee locking, clicking, or medial knee pain
  • Varus knee deformity with angle less than 10 degrees, mainly from the tibia
  • MRI showing medial meniscus posterior root tear
  • Knee X-rays showing narrowing of medial joint space and Kellgren-Lawrence grade less than IV
  • Failure of non-surgical treatment for more than 1 month
  • Willing to accept randomization and able to consent
  • For bilateral deformity, the more severely affected side will be operated
Not Eligible

You will not qualify if you...

  • Chronic knee locking preventing bending or straightening
  • Kellgren-Lawrence grade IV knee osteoarthritis
  • Osteoarthritis or other joint conditions affecting hip or ankle that impact knee function
  • Known inflammatory or autoimmune diseases affecting the knee
  • Active or past knee joint infection or reactive arthritis
  • Systemic cartilage or connective tissue disorders
  • Recent fractures within 6 months or osteonecrosis
  • Abnormal inflammatory blood markers making participation unsafe
  • Knee instability or inadequate ligament reconstruction
  • Prior surgery on target knee or other joints of the same leg
  • Serious heart, liver, kidney disease, cancer, bleeding disorders, immune deficiency, or severe mental health issues
  • Body mass index 30 or higher
  • Pregnant or breastfeeding, or unwilling to use contraception during the study
  • Participation in another clinical study within 3 months (except registries)
  • Any other condition that makes participation unsafe as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The Eighth Affiliated Hospital, Sun Yat-Sen University

Shenzhen, Guangdong, China, 518033

Actively Recruiting

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Research Team

H

Hanting Yi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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