Actively Recruiting
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
Led by Eighth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-05-04
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of surgeries for people with varus knee alignment and a tear at the back attachment of the medial meniscus. This pilot study aims to evaluate how a newer bone-cut procedure with arthroscopic meniscus repair compares to the standard bone-cut procedure with arthroscopic meniscus repair. The study will also track safety, pain relief, imaging results, meniscus healing, complications, hospital stay, and costs. Participants are randomly assigned to one of two groups: the experimental group will receive hemi-tibial plateau osteotomy combined with arthroscopic repair, and the control group will receive high tibial osteotomy combined with arthroscopic repair. Both procedures involve bone cutting guided by fluoroscopy and arthroscopic repair of the meniscus. The surgeries are performed during a hospital stay, with the osteotomy site stabilized by different fixation methods depending on the group. Participants will have screening and baseline assessments before surgery, followed by surgery during hospitalization. They will have follow-up visits at 3, 6, and 12 months after surgery to complete knee function and symptom questionnaires, pain ratings, standing knee and full-length leg X-rays, and knee MRIs to assess meniscus healing and extrusion. The main outcome measured is the change in the Lysholm knee function score from before surgery to 12 months after. Secondary outcomes include pain scores, arthritis symptoms, imaging measures, surgery details, complications, hospital stay length, costs, and quality of life assessments.
CONDITIONS
Brief Title
Hemi-tibial Plateau Osteotomy Combined With Arthroscopic Repair for Medial Meniscus Posterior Root Tears in Varus Knees
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 35 to 75 years, with no restriction on sex
- Clinical signs or symptoms suggesting a medial meniscus posterior root tear
- Varus knee deformity with a varus angle less than 10 degrees, mainly from the tibia
- Knee MRI confirming a medial meniscus posterior root tear
- Knee X-rays showing narrowing of the medial joint space and Kellgren-Lawrence grade less than IV
- No improvement after more than 1 month of conservative treatment
- Willing to accept randomization and able to provide informed consent
- For bilateral deformity, the more affected side is chosen for surgery
You will not qualify if you...
- Chronic knee locking preventing normal bending or straightening
- Kellgren-Lawrence grade IV knee osteoarthritis
- Osteoarthritis or other conditions in hip or ankle affecting knee function
- Known inflammatory or infectious diseases affecting the knee
- Knee instability or poor prior ligament reconstruction
- Prior surgery on the affected knee or other joints on the same leg
- Serious heart, liver, kidney disease, cancer, bleeding disorders, immune deficiency, or severe mental health issues
- Body mass index 30 or higher
- Pregnancy, breastfeeding, or unwillingness to use contraception during the study
- Participation in another clinical study within 3 months before enrollment
- Any other condition judged by the investigator to make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo hemi-tibial plateau osteotomy combined with arthroscopic repair or high tibial osteotomy combined with arthroscopic repair to treat medial meniscus posterior root tears in varus knees.
1 surgical visit (in-person)
Duration - 12 months
Participants are monitored for recovery and knee function improvement after surgery.
Visits at baseline (preoperative), 3 months, 6 months, and 12 months after surgery
Trial Site Locations
Total: 1 location
1
The Eighth Affiliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, China, 518033
Actively Recruiting
Research Team
H
Hanting Yi
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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