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

Summary

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

• Knee Osteoarthristis
• Meniscus Injury

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 continuity at the hinge area to protect the cartilage and meniscus. A controlled valgus force is then applied to gradually open the osteotomy gap, and the lower-limb alignment is corrected to the preplanned target and confirmed by fluoroscopy. Arthroscopic repair of the medial meniscus posterior root is subsequently performed. The distal attachment of the superficial medial collateral ligament is advanced proximally and fixed below the horizontal osteotomy line, and the osteotomy is stabilized with a

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 evaluation is then performed, followed by arthroscopic repair of the medial meniscus posterior root. The osteotomy site is stabilized with a proximal medial tibial anatomic locking titanium plate, and final fluoroscopic confirmation of alignment and fixation stability is obtained before wound closure.

Sponsors & Collaborators

• Eighth Affiliated Hospital, Sun Yat-sen University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• China

Study Locations