Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Study groups:
Who may join:
Who cannot join:
What participants will do:
Outcomes:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemi-tibial plateau osteotomy combined with arthroscopic repair | Experimental |
| |
| High tibial osteotomy combined with arthroscopic repair | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemi-tibial plateau osteotomy combined with arthroscopic repair | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lysholm Knee Score (12 months) | Lysholm knee score will be assessed preoperatively (baseline) and at 12 months after surgery. The primary endpoint is the change from baseline to 12 months (12-month score minus baseline score). Higher scores indicate better knee function. | Baseline (preoperative) and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lysholm Knee Score (3 and 6 Months) | Lysholm knee score will be assessed at baseline (preoperative) and at 3 and 6 months after surgery. The outcome is change from baseline at each time point (score at follow-up minus baseline score). Higher scores indicate better knee function. | Baseline (preoperative), 3 months, and 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in EQ-5D-5L Health Utility Value | Health-related quality of life will be assessed using the EQ-5D-5L questionnaire and converted to a health utility value using the China EQ-5D-5L value set. The outcome is the utility value at each time point and change from baseline (follow-up minus baseline). | Baseline (screening/preoperative), 0-7 days after surgery, 3 months, 6 months, and 12 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanting Yi | Contact | 852-52091055 | yiht6@mail2.sysu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eighth Affiliated Hospital, Sun Yat-Sen University | Recruiting | Shenzhen | Guangdong | 518033 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| High tibial osteotomy combined with arthroscopic repair | Procedure | 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. |
|
| Change From Baseline in WOMAC Total Score (3, 6, and 12 Months) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score will be assessed at baseline and at 3, 6, and 12 months after surgery. The outcome is change from baseline at each time point (follow-up minus baseline). WOMAC total score ranges from 0 to 96, with lower scores indicating better symptoms/function. | Baseline (preoperative), 3 months, 6 months, and 12 months after surgery |
| Change From Baseline in Pain Score (VAS) (3, 6, and 12 Months) | Pain will be assessed using a 10-cm visual analogue scale (VAS) at baseline and at 3, 6, and 12 months after surgery. The outcome is change from baseline at each time point (follow-up minus baseline). The VAS ranges from 0 (no pain) to 10 (worst pain). | 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 | On bilateral standing full-length lower limb radiographs, the mechanical axis (MA) will be evaluated by the relative location where the mechanical axis crosses the tibial plateau, expressed as a percentage (%MA). The outcome is %MA at each time point and change from baseline. | Baseline (preoperative), 3 months, 6 months, and 12 months after surgery |
| Quality-Adjusted Life Years (QALYs) Over 12 Months | QALYs will be calculated over the 12-month follow-up period using EQ-5D-5L utility values collected at scheduled visits (area-under-the-curve approach). The outcome is total QALYs accrued from baseline to 12 months. | Baseline to 12 months after surgery |
| Change in Kellgren-Lawrence Grade on Knee Radiographs | Kellgren-Lawrence (K-L) grade will be assessed on knee radiographs at each time point to evaluate radiographic severity of knee osteoarthritis (grades 0-IV). The outcome is K-L grade at each time point. | Baseline (preoperative), 3 months, 6 months, and 12 months after surgery |
| Bone Healing Grade at the Osteotomy Site (Modified Van Hemert System) | Bone healing at the osteotomy site will be graded using a modified Van Hemert system on radiographs. Grades range from 1 to 5, where higher grades indicate more bridging callus and better healing (grade 5 indicates complete bridging). The outcome is healing grade at each time point. | 0-7 days after surgery, 3 months, 6 months, and 12 months after surgery |
| Medial Meniscus Healing Status on MRI | Medial meniscus posterior root healing will be assessed on MRI and categorized as complete healing, partial healing, or non-healing. Complete healing is defined as continuity of the repaired root seen on all three MRI planes (sagittal, coronal, and axial). Partial healing indicates loss of continuity in any one plane, and non-healing indicates no continuity in any plane. The outcome includes healing category and the proportion of participants in each category at each time point. | Baseline (preoperative), 3 months, 6 months, and 12 months after surgery |
| Change in Medial Meniscus Extrusion Distance on MRI | Medial meniscus extrusion will be measured on MRI as the distance between the outer edge of the medial meniscus and the edge of the medial tibial plateau on a standardized reference line. Outcomes include extrusion distance at each time point and change from baseline. | Baseline (preoperative), 3 months, 6 months, and 12 months after surgery |
| Surgery-Related Outcomes, Complications, and Hospital Resource Use | Surgery-related outcomes will include operative time and intraoperative blood loss. Safety outcomes will include intraoperative and postoperative complications (e.g., common peroneal nerve injury, deep vein thrombosis, infection, implant failure, delayed union, or nonunion). Hospital resource use will include length of hospital stay and hospitalization costs. Outcomes will be recorded during the perioperative period and through 12 months after surgery. | 0-7 days after surgery; 3 months, 6 months, and 12 months after surgery (complications assessed through 12 months) |
| Change in Joint Line Convergence Angle (JLCA) on Standing Knee Radiographs | JLCA will be measured on standing anteroposterior knee radiographs. The outcome is JLCA (degrees) at each time point and change from baseline (follow-up minus baseline). | Baseline (preoperative), 3 months, 6 months, and 12 months after surgery |
| Change in Medial Joint Space Width (JS) on Standing Knee Radiographs | Medial joint space width will be measured on standing anteroposterior knee radiographs. The outcome is joint space width (e.g., mm) at each time point and change from baseline (follow-up minus baseline). | Baseline (preoperative), 3 months, 6 months, and 12 months after surgery |
| Change in Posterior Proximal Tibial Angle (PPTA) on Knee Radiographs | PPTA will be measured on knee radiographs. The outcome is PPTA (degrees) at each time point and change from baseline (follow-up minus baseline). | Baseline (preoperative), 3 months, 6 months, and 12 months after surgery |
| Change in Posterior Tibial Slope (PTS) on Lateral Knee Radiographs | Posterior tibial slope will be measured on lateral knee radiographs. The outcome is PTS (degrees) at each time point and change from baseline (follow-up minus baseline). | Posterior tibial slope will be measured on lateral knee radiographs. The outcome is PTS (degrees) at each time point and change from baseline (follow-up minus baseline). |