Meniscus Centralization for Meniscus Tears

Not yet recruiting at 2 trial locations
SD
Overseen BySejal Dave
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether repairing a specific knee cartilage tear, known as a medial meniscus posterior root tear, with or without a technique called centralization, affects pain, function, and overall patient satisfaction after surgery. The study includes two groups: one will receive the standard repair with centralization, and the other will undergo the repair without it. Individuals diagnosed with a medial meniscus posterior root tear and notable cartilage displacement (extrusion) seen on an MRI, who can commit to the trial schedule, might be suitable candidates.

As an unphased trial, this study offers participants the chance to contribute to medical knowledge and potentially improve future treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that repairing a tear in the back part of the knee's cartilage (medial meniscus posterior root tear, or MMPRT) using a method called centralization is generally safe and well-tolerated. Studies have found that complications are rare with this technique. For instance, one study noted a 26.9% failure rate, indicating that most patients did not face major problems.

This repair method has also been associated with positive outcomes, such as reducing the chance of the meniscus moving out of place and improving the space in the knee joint, which are good indicators of safety and effectiveness. Furthermore, after 10 years, 78% of these repairs showed no signs of wear and tear, suggesting long-term safety.

For MMPRT repair without using centralization, specific safety data is less detailed, but it remains a standard procedure and is generally considered safe based on current surgical practices.

Overall, evidence suggests that both methods are usually well-tolerated with minimal risks for most patients.12345

Why are researchers excited about this trial?

Researchers are excited about the technique of meniscus centralization for treating medial meniscus posterior root tears (MMPRT) because it aims to improve the results of the surgical repair. Unlike the standard MMPRT repair, which focuses solely on repairing the tear, meniscus centralization works by realigning the meniscus to its natural position, potentially enhancing joint stability and preserving knee function. This could lead to better long-term outcomes and reduce the likelihood of osteoarthritis, which is a common concern with traditional repair methods.

What evidence suggests that this trial's treatments could be effective for meniscus tears?

This trial will compare two surgical approaches for repairing a medial meniscus posterior root tear (MMPRT): one with meniscus centralization and one without. Research has shown that repairing a tear in the back part of the knee's meniscus using centralization can greatly improve knee function. Studies have found that this method reduces meniscus slipping and increases joint space, leading to better outcomes. This technique also enhances knee stability, potentially simplifying the surgery. Although there is a chance it might not work, the benefits of less pain and improved knee function are significant. In short, adding centralization to this type of meniscus repair seems to offer important benefits for knee health and recovery.12467

Who Is on the Research Team?

AJ

Aaron J. Krych, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with a specific knee injury called Medial Meniscus Posterior Root Tear (MMPRT). The study aims to include those who require surgical repair of this tear and are suitable candidates for the procedure.

Inclusion Criteria

Patient agrees to comply with trial schedules and plan
Notable extrusion (>3 mm) on preoperative MRI
Complete radial tears within 9 mm of medial meniscus posterior root
See 3 more

Exclusion Criteria

My knee joint damage is not severe on both sides.
My knee moves outward when I stand or walk.
Meniscal extrusion > 6 mm on pre-operative MRI
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Participants undergo medial meniscus posterior root tear surgical repair with or without centralization

1 day
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for changes in pain, function, and activity levels using various questionnaires

6 months
Multiple visits (in-person and virtual) at 2 weeks, 6 weeks, 3 months, and 6 months

Follow-up

Participants are monitored for long-term outcomes including knee function and satisfaction

24 months
Visits at 12 months and 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Medial meniscus posterior root tear (MMPRT) repair with meniscus centralization
  • Medial meniscus posterior root tear (MMPRT) repair without meniscus centralization

Trial Overview

The study is testing two surgical techniques for MMPRT: one includes an additional step called meniscus centralization, while the other does not. The goal is to see which method better improves pain, function, activity levels, satisfaction, and reduces further surgeries.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Repair with meniscus centralizationExperimental Treatment1 Intervention
Group II: Repair without centralizationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Clinical effect of medial meniscus posterior root repair ... - PMC

Both medial meniscus root repair and its combination with the centralization technique under arthroscopy can significantly enhance knee joint ...

Satisfactory Clinical Outcome, Complications, and ...

Early surgical repair of medial meniscus posterior root tear minimizes the progression of meniscal extrusion: 2-year follow-up of clinical and radiographic ...

Meniscal centralization significantly improve clinical outcomes ...

Imaging showed reduced meniscal extrusion and improved joint space width. Complications were minimal, though one study reported a 26.9% failure ...

Arthroscopic Medial Meniscus Posterior Root Repair and ...

It enhances biomechanical stability, minimizes extrusion, and reduces surgical complexity potentially leading to better outcomes in treating ...

Centralization for reducing medial meniscal extrusion after ...

Longitudinal changes in medial meniscus extrusion and clinical outcomes following pullout repair for medial meniscus posterior root tears: a 3- year evaluation.

Early Clinical Results Are Promising for Meniscus ...

Augmentation of the pullout repair of a medial meniscus posterior root tear by arthroscopic centralization. Arthrosc Tech. 2017; 6:e1335 ...

Review Meniscus repair and centralization: Preserving ...

However, after more than 10 years of follow-up, 78% of the meniscal repairs showed no radiographic degenerative changes compared with 64% of the partial ...