Meniscus Tear
Conditions
Keywords
Meniscus tear, Meniscus extrusion, Medial meniscus root repair, Meniscus centralization
Brief summary
The purpose of this research is to determine if meniscus root repair with or without centralization will have an impact on postoperative pain, function, activity levels, patient satisfaction, and incidence of revision meniscus surgery.
Interventions
PROCEDUREMedial meniscus posterior root tear (MMPRT) repair with meniscus centralization
The centralization technique involves placement of 1.8-mm Knotless FiberTak suture anchors along the periphery of the tibial plateau, starting from the posteromedial corner and progressing anteriorly. The anchors are deployed using a curved drill guide, and sutures are passed in a mattress configuration to re-tension the meniscotibial ligament to centralize the meniscus. Once centralization is complete, the posterior root tear is repaired using an anatomic suture anchor for aperture medial meniscus root fixation.
PROCEDUREMedial meniscus posterior root tear (MMPRT) repair without meniscus centralization
The posterior root tear is repaired using an anatomic suture anchor for aperture medial meniscus root fixation.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 Medial Meniscus Posterior Root Tear demonstrated on MRI * Notable extrusion (\>3 mm) on preoperative MRI * Patient able to consent for themselves * Patient agrees to comply with trial schedules and plan Pre-operative Exclusion: * Concomitant ligamentous or meniscal procedures * Meniscal extrusion \> 6 mm on pre-operative MRI * Kellgren-Lawrence grade \> 2 * Varus malalignment \> 10 degrees * Asymmetric varus alignment \> 5 degrees * Varus thrust while weightbearing * Grade 3 bipolar medial compartment changes (isolated grade 3 changes on single articular surface with ≤ grade 2 changes on the opposing surface remains eligible) * Previous surgery of the affected knee * Associated fractures requiring surgery * Concurrent Vascular injuries * Hypermobility/Ehlers-Danlos Syndrome * Inflammatory or autoimmune disease * Severe mental/physical disability precluding post operative rehabilitation demands * Contraindications to MRI * Pregnant women Arthroscopy Inclusion Criteria: * Complete radial tears within 9 mm of medial meniscus posterior root * ICRS Grade 3 or better Arthroscopy
Exclusion criteria
* Requiring concomitant procedures other than MMPRT * ICRS Grade 4 changes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Meniscus extrusion measurement | Baseline (Preoperatively), 6 months | Meniscus extrusion is measured in millimeters (mm) on coronal MRI at the level of the tibial spine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Kellgren-Lawrence grade on X-ray | Baseline (Screening), 12 months, 24 months | The Kellgren-Lawrence (KL) system is a 0-4 scale used to grade the severity of knee osteoarthritis (OA) based on X-ray. It ranges from Grade 0 (no changes) to Grade 4 (severe). |
| Change in Tegner Activity Score | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months | The Tegner Activity Questionnaire is a 1-item questionnaire rating physical activity from 0 (Disabled) to 10 (Elite competitive athlete). Total scores range from 0 - 10, with higher scores indicating a higher level of activity. |
| Change in Visual Analog Scale (VAS) Questionnaire score | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months | The VAS is a 2-item questionnaire assessing pain using a scale of 0 (No pain) to 10 (Worst pain). Total scores range from 0 - 10, lower scores indicating lower pain and higher scores indicating greater pain. |
| Change in Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS, JR) Questionnaire score | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months | The KOOS JR is a questionnaire designed to measure outcomes for patients with knee replacements. Questions focus on knee stiffness, pain, and function for daily activities and are assessed on a 5 point Likert-scale between 0 (None) and 4 (Extreme). Total scores range from 0 - 28, with higher scores indicating a greater impact of pain on daily functioning. |
| Change in International Knee Documentation Committee (IKDC) Questionnaire score | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months | The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation assesses overall function over 3 domains: symptoms, athletic activity, and knee function. Higher scores indicate higher levels of function and lower levels of symptoms. |
| Change in Likert Knee Questionnaire score | Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months | The Likert Knee Questionnaire is a 1-item survey asking the patient to rate knee pain post-surgery on a Likert scale where 0 (Much better than before surgery) and 5 (Much worse than before surgery). |
| Surgery Satisfaction Questionnaire | 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months | The Surgery Satisfaction Questionnaire is a 1-item survey asking the patient to rate satisfaction with knee surgery on a Likert scale where 0 (Not at all) and 10 (Most Satisfied). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAaron J. Krych, MD
Mayo Clinic
Outcome results
None listed